US20070021819A1 - Apparatus and Methods for Locating an Ostium of a Vessel - Google Patents
Apparatus and Methods for Locating an Ostium of a Vessel Download PDFInfo
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- US20070021819A1 US20070021819A1 US11/419,997 US41999706A US2007021819A1 US 20070021819 A1 US20070021819 A1 US 20070021819A1 US 41999706 A US41999706 A US 41999706A US 2007021819 A1 US2007021819 A1 US 2007021819A1
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- locator
- loop
- distal portion
- ostium
- struts
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Definitions
- the present invention relates generally to apparatus and methods for locating an ostium of a blood vessel or other body lumen, and, more particularly, to apparatus and methods for locating an ostium of a blood vessel or other body lumen to deliver a stent or other prosthesis into or adjacent the ostium.
- Tubular endoprosthesis or “stents” have been suggested for dilating or otherwise treating stenoses, occlusions, and/or other lesions within a patient's vasculature or other body lumens.
- a self-expanding stent may be maintained on a catheter in a contracted condition, e.g., by an overlying sheath or other constraint, and delivered into a target location, e.g., a stenosis within a blood vessel or other body lumen.
- the constraint may be removed, whereupon the stent may automatically expand to dilate or otherwise line the vessel at the target location.
- a balloon-expandable stent may be carried on a catheter, e.g., crimped or otherwise secured over a balloon, in a contracted condition.
- the balloon When the stent is positioned at the target location, the balloon may be inflated to expand the stent and dilate the vessel.
- a stenosis or other lesion may occur at an ostium or bifurcation, i.e., where a branch vessel extends from a main vessel.
- a branch vessel extends from a main vessel.
- a lesion may form within a coronary artery immediately adjacent the aortic root.
- U.S. Pat. No. 5,749,890 to Shaknovich discloses a stent delivery assembly for placing a stent in an ostial lesion.
- U.S. Pat. No. 5,632,762 to Myler discloses a tapered balloon on a catheter for positioning a stent within an ostium.
- 5,607,444 to Lam discloses an expandable ostial stent including a tubular body and a deformable flaring portion.
- Published application US 2002/0077691 to Nachtigall discloses a delivery system that includes a sheath for holding a stent in a compressed state during delivery and a retainer that holds a deployable stop in an undeployed position while the delivery system is advanced to a desired location.
- apparatus and methods for locating an ostium and/or for delivering a stent within an ostium would be useful.
- the present invention is directed to apparatus and methods for locating a branch body lumen extending from a main body lumen, and, more particularly, to apparatus and methods for locating an ostium or bifurcation of a blood vessel or other body lumen, e.g., for delivering a stent or other prosthesis within or adjacent the ostium and/or for accessing the blood vessel.
- an apparatus in accordance with one embodiment, includes a tubular member including proximal and distal ends, and a lumen extending between the proximal and distal ends, an elongate member including a distal portion disposed within the lumen such that the distal portion may be advanced beyond the tubular member distal end, an expandable locator on the distal portion.
- the locator includes a loop including first and second ends fixed to the distal portion, first and second resilient struts extending from the first and second ends, respectively, and a curved intermediate region extending between the first and second struts.
- the loop may be resiliently compressible to a contracted condition when the distal portion is disposed within the lumen and resiliently expandable to an enlarged condition when the distal portion is advanced beyond the tubular member distal end.
- the loop may substantially define a plane in the enlarged condition and/or the plane may define an acute angle with a longitudinal axis of the tubular member.
- the loop may be twisted asymmetrically relative to a longitudinal axis of the tubular member in the enlarged condition.
- only a single loop or a plurality of expandable loops may be provided on the distal portion of the tubular member. If a plurality of expandable loops are provided, the loops may be disposed symmetrically or asymmetrically around a circumference of the tubular member. In one embodiment, the plurality of expandable loops may include curved intermediate regions that generally define a portion of an ellipse surrounding the distal portion.
- an apparatus for locating an ostium of a body lumen.
- the apparatus includes an elongate member including a distal portion that may advanced through a guide catheter or other tubular member, and a plurality of expandable loops on the distal portion.
- Each loop may include first and second resilient struts extending from the distal portion, and a curved intermediate region extending between the first and second struts.
- each loop may be resiliently compressible to a contracted condition when the distal portion is disposed within the tubular member and resiliently expandable to an enlarged condition when the distal portion is advanced from the tubular member.
- the loops may be disposed around the distal portion such that the intermediate regions define at least a portion of an ellipse surrounding the distal portion when the loops are in the enlarged condition.
- the struts may be resiliently deflectable when the loops are expanded to the enlarged condition to provide tactile feedback when one or more of the intermediate regions contact an ostium.
- a tubular prosthesis may be provided on the distal portion, e.g., adjacent the loops such that the apparatus may be used to position the prosthesis within an ostium.
- an apparatus for locating an ostium of a body lumen that includes a tubular member including a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion.
- One or more locator elements may be disposed asymmetrically on the distal portion, each locator element including a first end fixed to the distal portion and a second end free from the distal portion.
- Each locator element may be resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device, and each locator element being resiliently expandable to an enlarged condition when fully deployed from the delivery device.
- a stent or other prosthesis may be disposed on the distal portion.
- an apparatus for locating an ostium of a body lumen that includes a tubular member including a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion, and a locator loop on the distal portion.
- the locator loop may be resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device and/or resiliently expandable to an enlarged condition when fully deployed from the delivery device.
- the locator loop may include a loop that substantially surrounds the distal portion of the tubular member in the enlarged condition, and a plurality of struts extending between the loop and the distal portion for attaching the locator loop to the tubular member.
- the struts may include an inner portion closer to the tubular member and an outer portion closer to the loop, the inner portion being more rigid than the outer portion.
- one or more supports may extend between adjacent struts at intermediate regions of the struts.
- the locator loop may include a base attached to the distal portion of the tubular member, the struts extending from the base.
- at least the base and the struts may be formed from a unitary tubular body.
- the loop may also be formed from the unitary tubular body, or the loop may be formed from one or more wires attached to the unitary tubular body.
- a method for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen.
- a distal end of a delivery catheter may be advanced into the main body lumen, the distal end including one or more locator elements constrained in a contracted condition.
- the one or more locator elements may be released within the main body lumen and directed against a wall of the ostium, and a procedure may be performed at or within the ostium based upon the position of the one or more locator elements in the enlarged condition, e.g., a stent may be delivered into the ostium.
- the one or more locator elements may assume an asymmetrical orientation upon being released and/or may cause the distal end of the delivery catheter to rotate about its longitudinal axis when the locator elements are released.
- the one or more locator elements may provide tactile feedback resisting further advancement when the one or more locator elements contact the main body lumen wall adjacent the ostium.
- a method for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen.
- a distal end of a delivery catheter may be advanced into the main body lumen, and one or more locator elements on the distal end may be released within the main body lumen, the one or more locator elements resiliently expanding to substantially surround the distal end.
- the one or more locator elements may be directed against a wall of the ostium, thereby causing one or more struts supporting the one or more locator elements to bend away from the ostium.
- a procedure e.g., stent delivery, may then be performed at or within the ostium based upon the position of the one or more locator elements in the enlarged condition.
- FIG. 1 is a perspective view of an apparatus for delivering a stent, including a guide catheter and a delivery catheter, the delivery catheter having a distal end carrying a locator loop adjacent a balloon over which a stent is maintained.
- FIG. 2 is a cross-sectional view of the catheter of FIG. 1 , taken along line 2 - 2 , with the locator loop expanded.
- FIGS. 3 and 4 are cross-sectional views of alternate embodiments of delivery catheters including multiple locator loops.
- FIGS. 5-10 are cross-sectional views of a patient's body, showing a method for implanting a stent within an ostium of a body lumen using the apparatus of FIG. 1 .
- FIGS. 11 and 12 are cross-sectional views of a patient's body, comparing a method for locating an ostium using locator loops that are disposed around a circumference of a delivery catheter with a method using one or more locator loops that are disposed on only one side of a circumference of a delivery catheter.
- FIGS. 13A-13C are side, perspective, and ends views, respectively, of a locator including a single locator loop expanded transversely from a delivery catheter.
- FIGS. 14A-14C are side, perspective, and ends views, respectively, of a locator including a pair of locator loops adjacent on another on one side of a delivery catheter.
- FIGS. 15A-15C are perspective, and ends views, respectively, of a locator including three locator loops disposed symmetrically around a circumference of a delivery catheter.
- FIGS. 16A-16C are side, perspective, and ends views, respectively, of another locator including a single locator loop having a curved tip and expanded transversely from a delivery catheter.
- FIGS. 17A-17C are side, perspective, and ends views, respectively, of yet another locator including a single locator loop expanded transversely from a delivery catheter.
- FIGS. 18A-18C are side, perspective, and ends views, respectively, of another locator including a “D” shaped locator loop expanded transversely from a delivery catheter.
- FIGS. 19A-19C are side, perspective, and ends views, respectively, of still another locator including a “D” shaped locator loop extending transversely from a leg attached to a delivery catheter.
- FIGS. 20A-20C are side, perspective, and ends views, respectively, of yet another locator including a pair of “D” shaped locator loops expanded transversely from a delivery catheter.
- FIGS. 21A-21C are side, perspective, and ends views, respectively, of another locator including a narrow, curved locator loop expanded transversely from a delivery catheter.
- FIGS. 22A-22C are side, perspective, and ends views, respectively, of yet another locator including a narrow, curved locator loop expanded transversely from a delivery catheter.
- FIGS. 23A-23C are side, perspective, and ends views, respectively, of another locator including a pair of narrow, curved locator loop expanded transversely from a delivery catheter.
- FIGS. 24A-24C are side, perspective, and ends views, respectively, of another locator including three narrow, curved locator loop expanded transversely from a delivery catheter.
- FIGS. 25A-25C are side, perspective, and ends views, respectively, of a locator including a locator loop expanded transversely and asymmetrically from a delivery catheter.
- FIGS. 26A-26C are side, perspective, and ends views, respectively, of another locator including a locator loop expanded transversely and asymmetrically from a delivery catheter.
- FIGS. 27A-27C are side, perspective, and ends views, respectively, of still another locator including a locator loop expanded transversely and asymmetrically from a delivery catheter.
- FIGS. 28A-28C are side, perspective, and ends views, respectively, of a locator including a pair of locator loops expanded transversely and asymmetrically from a delivery catheter.
- FIGS. 29A-29C are side, perspective, and ends views, respectively, of a locator including three locator loops expanded transversely and asymmetrically from a delivery catheter.
- FIGS. 30A-30D are perspective views of a locator loop being deployed from a guide catheter, the locator loop automatically rotating about a longitudinal axis during deployment.
- FIGS. 31A-31D are perspective views of a locator loop being deployed from a guide catheter as the apparatus is advanced into an ostium.
- FIG. 32 is a perspective view of another embodiment of a delivery catheter including an expandable frame adjacent a stent balloon, with the frame expanded to provide a locator loop.
- FIG. 33A is a perspective view of yet another embodiment of a delivery catheter including an expandable frame adjacent a stent balloon, with the frame expanded to provide a locator loop.
- FIG. 33B is a perspective detail of the frame of the delivery catheter of FIG. 33A .
- FIG. 33C is an end view detail of the frame of the delivery catheter of FIG. 33A .
- FIGS. 34A-34F are cross-sectional views of a patient's body, showing a method for implanting a stent using the delivery catheter of FIG. 32 .
- FIG. 35 is a perspective view of an expanded locator loop that may be provided on a delivery catheter.
- FIGS. 36A-36C are top views of alternate patterns that may be cut from a tube to provide the locator loop of FIG. 35 , the pattern being shown flat for clarity.
- FIG. 37 is a top view of another pattern including a portion cut from a tube and a wire portion used to provide the locator loop of FIG. 35 , the pattern being shown flat for clarity.
- FIGS. 38A-38D are top views of additional patterns that may be cut from a tube to provide the locator loop of FIG. 35 , the pattern being shown flat for clarity.
- FIGS. 39A and 39B are side views of another embodiment of a stent delivery catheter including a plurality of locator arms adjacent the stent that are movable between collapsed and expanded configurations, respectively.
- FIGS. 40A-40C are details of the stent delivery catheter of FIGS. 39A and 39B , showing different balloon and stent configurations that may be provided.
- FIG. 41 is a detail of a tip that may be provided on ends of the locator arms of the delivery catheter of FIGS. 39A and 39B .
- FIGS. 42A and 42B are details of alternative tips that may be provided on ends of the locator arms of the delivery catheter of FIGS. 39A and 39B .
- FIGS. 43A-43D are side views of another locator arm configuration that may be provided on a delivery catheter.
- FIGS. 44A and 44B are details of yet another tip that may be provided on ends of the locator arms of the delivery catheter of FIGS. 39A and 39B .
- FIGS. 45A-45F are cross-sectional views of a patient's body, showing a method for implanting a stent in an ostium using a locator device including a balloon on a guide catheter.
- FIGS. 46A and 46B are side views of another embodiment of a locator device including a balloon-expandable braid on a guide catheter movable between collapsed and expanded configurations, respectively.
- FIG. 47 is a side view of an alternate embodiment of the locator device of FIGS. 46B .
- FIGS. 48A and 48B are cross-sectional views of a patient's body, showing a method for accessing an ostium using the locator device of FIG. 47 .
- FIGS. 49A and 49B are side views of another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by retracting an overlying sheath.
- FIGS. 50A and 50B are side views of another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by inflating an underlying balloon.
- FIGS. 51A and 51B are side views of yet another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by retracting an overlying sheath.
- FIG. 51C is a detail of the locator device of FIGS. 51A and 51B , showing an exemplary arm extending through a slit in the sheath.
- FIGS. 52A-52C are details showing alternate tips that may be provided on the arms of the locator devices shown in FIGS. 49A-51C .
- FIGS. 53A and 53B are side views of yet another embodiment of a locator device including an expandable braid on a guide catheter that is movable between collapsed and expanded configurations, respectively.
- FIGS. 54A and 54B are cross-sectional details, showing alternative constructions for a tip of the locator device of FIGS. 53A and 53B .
- FIGS. 55A and 55B are side views of still another embodiment of a locator device including a plurality of expandable splines on a guide catheter that are movable between collapsed and expanded configurations, respectively.
- FIGS. 56A and 56B are side views of yet another embodiment of a locator device including a plurality of expandable splines or arms on a guide catheter that are movable between collapsed and expanded configurations, respectively.
- FIGS. 57A-57C are side views of another embodiment of a locator device including a plurality of everting wires that are deployable from a guide catheter.
- FIGS. 58A-58F are perspective views of a locator loop being deployed from a guide catheter, the locator loop automatically rotating about a longitudinal axis during deployment.
- FIG. 1 shows an exemplary embodiment of an apparatus 10 for delivering a stent or other prosthesis 40 , e.g., into an ostium or other bifurcation between a main lumen and a branch lumen (not shown).
- the apparatus 10 includes a catheter or other elongate tubular member 12 having a proximal end 14 , a distal end 16 , and one or more lumens 18 extending between the proximal and distal ends 14 , 16 , thereby defining a longitudinal axis 20 between the proximal and distal ends 14 , 16 .
- the delivery catheter 12 includes a locator loop 50 on the distal end 16 , e.g., proximal or otherwise adjacent to a stent 40 also carried on the distal end 16 , which may be any of the locator loops described herein.
- a locator loop 50 on the distal end 16 , e.g., proximal or otherwise adjacent to a stent 40 also carried on the distal end 16 , which may be any of the locator loops described herein.
- one or more balloons or other expandable members 22 may be provided on the distal end 16 of the delivery catheter 12 for expanding and/or deploying the stent 40 , as described further below.
- the apparatus 10 may include a guide catheter 60 including a proximal end 62 , a distal end 64 , and a lumen 66 extending therebetween.
- the distal end 64 may be sized and/or shaped to facilitate advancement into a patient's vasculature or other body lumen, as described further below.
- the lumen 66 may have sufficient size for receiving the distal end 16 of the delivery catheter 12 therethrough, e.g., with the locator loop 50 in a contracted condition, also as explained further below.
- the distal end 64 of the guide catheter 60 may be biased to a predetermined shape, e.g., a “J” shape, which may facilitate positioning the guide catheter 60 within or adjacent an ostium.
- the guide catheter 60 may be constructed from substantially flexible and/or floppy materials, e.g., plastic having a braid or other reinforcement (not shown) that sufficiently supports the guide catheter 60 to prevent kinking or buckling, while allowing the guide catheter 60 to be directed easily through tortuous anatomy.
- the apparatus 10 may include other components to provide a system or kit for delivering the stent 40 , e.g., a sheath that may be advanced over and/or retracted from the distal end 16 of the delivery catheter 12 , one or more syringes or other sources of inflation media and/or vacuum, tubing, and/or one or more guidewires (all not shown).
- the delivery catheter 12 may be formed from one or more tubular bodies, e.g., having variable flexibility along its length.
- the distal end 16 may be substantially flexible to facilitate insertion through tortuous anatomy, e.g., terminating in a rounded, tapered, and/or other substantially atraumatic distal tip 17 .
- the distal end 16 may be sized and/or shaped for introduction into a body lumen, e.g., having a diameter between about one and seven millimeters (1-7 mm), or less than 1.5 millimeters.
- the proximal end 14 may be substantially flexible or semi-rigid, e.g., having sufficient column strength to facilitate advancing the distal end 16 through a patient's vasculature by pushing on the proximal end 14 .
- the delivery catheter 12 may be formed from plastic, metal, or composite materials, e.g., a plastic material having a wire, braid, or coil core, which may preventing kinking or buckling of the catheter 12 during advancement.
- the delivery catheter 12 may include a handle 30 on the proximal end 14 , e.g., to facilitate manipulating the delivery catheter 12 .
- the handle 30 may include one or more side ports 32 communicating with respective lumens 18 within the delivery catheter 12 .
- the handle 30 may be molded, machined, or otherwise formed from plastic, metal, or composite material, e.g., providing an outer casing, which may be contoured or otherwise shaped to ease manipulation.
- the proximal end 14 of the delivery catheter 12 may be attached to the handle 30 , e.g., by bonding, cooperating connectors, interference fit, and the like.
- the handle 30 may include one or more actuators (not shown), such as one or more slides, dials, buttons, and the like, for actuating or otherwise manipulating the components on the distal end 16 from the proximal end 14 , as explained further below.
- the delivery catheter 12 includes at least two lumens 18 extending between the proximal ends 14 , 16 .
- the delivery catheter 12 may include a guidewire or instrument lumen that extends from a port 32 a in the handle 30 to an opening 34 in the distal tip 17 .
- the instrument lumen may have sufficient size to allow a guidewire or other rail or instrument (not shown) to be inserted therethrough, e.g., to facilitate advancing the delivery catheter 12 over the rail, as explained further below.
- the handle 30 may include one or more seals (not shown) within or adjacent the port 32 a , e.g., e.g., a hemostatic seal that prevents fluid, e.g., blood, from flowing proximally out of the port 32 a , yet allows one or more instruments to be inserted therethrough and into the instrument lumen.
- seals e.g., a hemostatic seal that prevents fluid, e.g., blood, from flowing proximally out of the port 32 a , yet allows one or more instruments to be inserted therethrough and into the instrument lumen.
- the delivery catheter 12 may include one or more inflation lumens that extend from respective side port(s) 32 b in the handle 30 through the delivery catheter 12 to openings (not shown) that communicate with an interior of a respective balloon 22 .
- the side port(s) 32 b on the handle 30 may include connectors, e.g., a luer lock connector (not shown), one or more seals (also not shown), and the like.
- a source of inflation media and/or vacuum e.g., a syringe filled with saline (not shown), may be connected to the side port(s) 32 b , e.g., via tubing (also not shown), for expanding and/or collapsing the balloon 22 .
- the delivery catheter 12 includes one balloon 22 on the distal end 16 .
- the delivery catheter 12 may include multiple balloons (not shown) on the distal end 16 over which the stent 40 may be placed. Additional information on multiple balloon catheters and methods for using them are disclosed in co-pending application Ser. No. 11/136,266, filed May 23, 2005, and provisional application Ser. No. 60/745,177, filed Apr. 19, 2006. The entire disclosures of these references are expressly incorporated by reference herein.
- the balloon (or balloons, not shown) 22 may be bonded or otherwise secured to the distal end 16 of the delivery catheter 12 .
- ends of the balloon 22 may be attached to the distal end 16 using one or more of bonding with an adhesive, sonic welding, an annular collar or sleeve, and the like.
- the balloon 22 may be expandable from a contracted condition (not shown, see, e.g., FIG. 6 ), which may facilitate advancement through a patient's vasculature, to an enlarged condition for expanding or otherwise deploying the stent 40 .
- the balloon 22 may be formed from substantially inelastic material, e.g., PET, nylon, or PEBAX, such that the balloon 22 expands to a predetermined size in its enlarged condition once sufficient fluid is introduced into the interior of the balloon 22 .
- the balloon 22 may be formed from substantially elastic material, e.g., silicone, polyurethane, or polyethylene, such that the balloon 22 may be expanded to a variety of sizes depending upon the volume and/or pressure of fluid within the interior.
- the stent 40 may be formed from a variety of materials that may be plastically deformed to allow expansion of the stent 40 .
- the stent 40 may be formed from metal, such as stainless steel, tantalum, MP35N, Niobium, Nitinol, and L605, plastic, or composite materials.
- the materials of the stent 40 may be plastically deformed under the pressures experienced when the balloon 22 is expanded such that all or one or more portions of the stent 40 are deformed beyond their elastic limit.
- the stent 40 may maintain its expanded configuration with minimal recoil.
- the stent 40 material may resist collapsing back towards its reduced configuration if the tissue surrounding the body lumen attempts to constrict or otherwise return to its occluded shape.
- the stent 40 may be self-expanding.
- the stent 40 may be biased to expand at least partially outwardly yet may be constrained over the balloon 22 in a contracted condition to facilitate delivery, e.g., using a sheath, filament, and the like (not shown).
- the stent 40 may be formed from Nitinol or other shape memory or superelastic materials.
- the resistance of the stent 40 to expansion may be varied along its length. This performance of the stent 40 may be based upon mechanical properties of the material, e.g., which may involve heat treating one or more portions of the stent 40 differently than other portions.
- the structure of the stent 40 may be varied, e.g., by providing struts, fibers, or other components in different portions having different widths, thicknesses, geometry, and the like.
- the stent 40 may be a generally tubular structure, e.g., including openings in a tubular wall that facilitate expansion of the stent 40 and/or allow tissue ingrowth.
- the stent may be an elongate tube that has slots or other openings formed in the tube wall, e.g., by laser cutting, mechanical cutting, chemical etching, machining, and the like.
- the stent 40 may be a braided or other structure, e.g., formed from one or wires or other filaments braided or otherwise wound in a desired manner. Additional possible stent structures may include helical coil wires or sheets.
- one or more portions of the stent 40 may include a membrane, film, or coating (not shown), e.g., to create a nonporous, partially porous, or porous surface between cells of the stent 40 and/or to carry one or more therapeutic compounds.
- a membrane, film, or coating not shown
- Additional information on stents that may be delivered using the catheter 12 may be found in co-pending application Ser. No. 60/683,920, filed May 23, 2005, 60/710,521, filed Aug. 22, 2005, 60/731,568, filed Oct. 28, 2005, 60/757,600, filed Jan. 9, 2006, 60/743,880, filed Mar. 28, 2006, and 60/745,177, filed Apr. 19, 2006. The entire disclosures of these references are expressly incorporated by reference herein.
- the locator loop 50 is an expandable member including first and second ends 52 fixed to the distal end 16 of the delivery catheter 12 , first and second resilient struts 54 extending from the first and second ends 52 , respectively, and a curved intermediate region 56 extending between the first and second struts 54 .
- the locator loop 50 may formed from a single strand extending from the first end 52 , through the first struts 54 , the intermediate region 56 , and the second strut 54 to the second end 52 .
- the locator loop 50 may be formed from multiple strands that are wound about one another to form a braided or other structure.
- the locator loop 50 may include different sections of material for one or more regions of the locator loop 50 that are attached to one another, e.g., by bonding, melting, or fusing the ends, using connector bands, and the like (not shown).
- the locator loop 50 may be formed from a tube that has portions removed, e.g., similar to the construction of the stent 40 , as described further below.
- the locator loop 50 may be formed from an elastic or superelastic material, e.g., metal such as Nitinol, stainless steel, and the like, plastic, and/or composite materials (e.g., a metal wire core covered with a plastic coating).
- the locator loop 50 is generally resiliently compressible to a contracted condition, and biased to expand to an enlarged condition, such as that shown in FIGS. 13A-13C , when free from external forces.
- the locator loop 50 may be compressed against the distal end 16 of the delivery catheter 12 and constrained in the contracted condition, e.g., when the distal end 16 of the delivery catheter 12 is loaded into the lumen 66 of the guide catheter 60 .
- the struts 54 may extend substantially axially along the distal end 16 and the intermediate region 56 may be partially straightened, twisted, or otherwise compressed towards the surface of the distal end 16 .
- a sheath (not shown) may be provided that extends over the distal end 16 of the delivery catheter 12 to constrain the locator loop 50 (and/or cover the stent 40 and balloon 22 ).
- the locator loop 50 may resiliently expand to the enlarged condition.
- the ends 52 of the locator loop 50 may be attached or otherwise secured to the distal end 16 of the delivery catheter 12 .
- an adhesive, sonic welding, fusing, and the like may be used to bond the ends 52 to the surface of the distal end 16 .
- a band of material e.g., a heat shrink tube or other band of plastic, metal, wire, and the like, may be wrapped or otherwise extend around the ends 52 of the locator loop 50 .
- the ends 52 of the locator loop 50 may be at least partially embedded into the delivery catheter 12 , e.g., into slots or holes partially or completely penetrating the wall of the delivery catheter 12 .
- the ends 52 may be part of an annular band that may crimped or otherwise secured around the delivery catheter 12 , e.g., in addition to or instead of the other attachment methods described above.
- the struts 54 are relatively short, and the intermediate region 56 is relatively long, although in some embodiments described herein, the struts 54 may be substantially longer than the intermediate region 56 .
- the intermediate region 56 is generally curved, e.g., defining an arcuate shape approximating a portion of an ellipse or circle.
- the intermediate region 56 may generally define a surface, which may be substantially planar as shown in FIGS. 13A-13C or curved, as shown and described elsewhere herein.
- the intermediate region 56 may be biased to assume a more complicated curved geometry, as described further below.
- the struts 54 and/or intermediate region 56 may also be shaped such that the intermediate region 56 extends transversely relative to the longitudinal axis 20 of the catheter 12 .
- the struts 54 may be curved or otherwise transition from an axial direction to a transverse direction.
- the ends 52 may extend substantially axially, while the intermediate region 56 extends substantially perpendicular to the longitudinal axis 20 .
- the intermediate region 56 and/or other portions of the locator loop 50 may extend laterally relative to the longitudinal axis 20 , e.g., defining an acute or oblique angle with the longitudinal axis 20 .
- the locator loop 50 may have sufficient strength (e.g., column strength and/or bending resistance) to be self-supporting, yet be at partially deflectable, e.g., to provide tactile feedback to a user, as explained further below.
- one or more portions of the locator loop 50 e.g., the struts 54 and/or intermediate region 56 , may bend or flex when the locator loop 50 contacts and is pushed against a surface (e.g., a wall of a body lumen adjacent an ostium).
- the initial contact may provide a first tactile feedback, and thereafter resist further bending or flexing to provide a second or additional tactile feedback, as described further elsewhere herein.
- the ostium 90 may be an opening in a wall of a first or main body lumen or trunk 92 that communicates with a second body lumen or branch 94 .
- the trunk 92 may be the aortic root and the branch 94 may be a coronary artery.
- the trunk 92 may be the distal aorta, and the branch 94 may a renal artery or other abdominal branch.
- apparatus and methods described herein may be applicable to a variety of bifurcations or branches that extend transversely, e.g., laterally (for example, at relatively shallow angles) or substantially perpendicularly, from another body lumen or trunk, e.g., within a patient's vasculature or other systems.
- An occlusion or other lesion 96 may exist at and/or adjacent to the ostium 90 , e.g., extending at least partially into the branch 94 .
- the lesion 96 may include atherosclerotic plaque or other material that partially or completely occludes blood or other fluid flow between the trunk 92 and the branch 94 .
- a guidewire 98 or other rail may be introduced from the trunk 92 through the ostium 90 into the branch 94 .
- the lesion 96 at the ostium 90 partially occludes the ostium 90 and extends into the branch 94 .
- the guidewire 98 may be placed using conventional methods. For example, a percutaneous puncture or cut-down may be created at a peripheral location (not shown), such as a femoral artery, carotid artery, or other entry site, and the guidewire 98 may be advanced through the patient's vasculature from the entry site, e.g., alone or with the aid of guide catheter 60 .
- the guidewire 98 may be directed through the occlusion or other devices (not shown) may be advanced over the guidewire 98 or otherwise in conjunction with the guidewire 98 to create a passage through the lesion 96 for the guidewire 98 .
- an angioplasty catheter (not shown) may be advanced through the guide catheter 60 and/or over the guidewire 98 into and through the lesion 96 , whereupon a balloon or other element on the catheter may be expanded to at least partially dilate the lesion 96 .
- other procedures may also be performed at the lesion 96 , e.g., to soften, remove, or otherwise treat plaque or other material forming the lesion 96 , before the stent 40 is implanted. After completing any such procedures, instruments advanced over the guidewire 98 may be removed.
- the distal end 64 of the guide catheter 60 may be advanced over the guidewire 98 into the trunk 92 , e.g., until the distal end 64 is disposed adjacent or proximal to the ostium 90 .
- the guide catheter 60 may be used to advance one or more instruments (such as those just described) over the guidewire 98 and into the trunk 92 and/or branch 94 .
- a distal end 16 of the delivery catheter 12 may be advanced over the guidewire 98 and through the lumen 66 of the guide catheter 60 from the entry site into the trunk 92 .
- the locator loop 50 , balloon 22 , and stent 40 are carried in contracted conditions through the guide catheter 60 .
- the guide catheter 60 may allow the locator loop 50 to slide freely within the lumen 66 while remaining in the contracted condition.
- the locator loop 50 (and/or the guide catheter 60 ) may include a lubricious coating to reduce friction and/or otherwise facilitate advancement through the guide catheter 60 .
- the guide catheter 60 may be withdrawn from the ostium 90 to advance the distal end 16 out of the lumen 66 .
- the locator loop 50 may resiliently expand within the trunk 92 , as shown.
- the sheath may be retracted before or after deploying the distal end 16 of the catheter 12 from the guide catheter 60 . In this position, the distal tip 17 of the catheter 12 may extend into the ostium 90 , as shown, or may be located within the trunk 92 .
- the delivery catheter 12 may be advanced, thereby directing the distal end 16 into the ostium 90 , e.g., such that the distal tip 17 extends through the lesion 96 and into the branch 94 beyond.
- the locator loop 50 contacts and is pushed against the wall of the trunk 92 surrounding or adjacent the ostium 90 .
- This initial contact may be transmitted back to the proximal end (not shown) of the delivery catheter 12 due to the increased resistance to further advancement, thereby providing tactile feedback to the user of the location of the stent 40 relative to the ostium 90 .
- the delivery catheter 12 may be advanced further until the locator loop 50 bends, as shown, thereby preventing further distal movement. This increased resistance provides further tactile feedback that the distal end 16 of the delivery catheter 12 is positioned at an appropriate location for deploying the stent 40 .
- the relative location of the locator loop 50 to the stent 40 on the distal end 16 of the delivery catheter 12 may be predetermined such that the position where further distal movement is impeded by the locator loop 50 corresponds to the optimum distance into the ostium 90 and/or branch 94 for deploying the stent 40 .
- one or more radiopaque markers may be provided, e.g., on one or both ends of the stent 40 , on the catheter 12 or balloon 22 under one or both ends of the stent 40 , and/or on the locator loop 50 .
- the locator loop 50 may be made radiopaque through the incorporation of radiopaque materials in its construction, either as an integral part of the loop wire, or as a structure attached to the loop wire. Contrast may be delivered, e.g., via the delivery catheter 12 or through the guide catheter 60 (e.g., after advancing the guide catheter 60 until the distal end 64 contacts the ostium 90 ), to facilitate identifying the position of the stent 40 relative to the ostium 90 under fluoroscopy or other external imaging.
- the stent 40 may then be deployed within the ostium 90 and/or branch 94 .
- the balloon 22 may be inflated to expand the stent 40 , e.g., within the branch 94 immediately adjacent the ostium 90 to dilate and/or otherwise treat the lesion 96 .
- the balloon 22 may expand the stent 40 to a substantially uniform cylindrical shape as shown in FIG. 9 .
- the balloon 22 may expand the stent 40 to a frusto-conical or other tapered shape, similar to that shown in FIG. 40A .
- the delivery catheter 12 may include multiple balloons (not shown) under the stent 40 that may be used to expand portions of the stent 40 sequentially, as described in application Serial No. 11/136,266 or the other applications incorporated by reference above.
- a proximal balloon (not shown) may be inflated to expand a proximal portion of the stent 40 , e.g., into a flared configuration, adjacent the locator loop 50 .
- the delivery catheter 12 may be advanced distally, e.g., until the flared portion conforms or otherwise contacts the wall of the trunk 92 surrounding the ostium 90 .
- another balloon may be inflated to expand a distal portion of the stent 40 within the lesion 96 and/or branch 94 .
- the balloon(s) 22 may be collapsed, e.g., by evacuating the inflation media using a syringe or other device (not shown) at the proximal end (also not shown) of the delivery catheter 12 .
- the delivery catheter 12 may be withdrawn into the guide catheter 60 .
- the guide catheter 60 may be advanced towards or against the ostium 90 and/or against a proximal end of the stent 40 before the delivery catheter 12 is removed.
- This action may facilitate withdrawing the distal end 16 (e.g., the balloon 22 ) back through the stent 40 , e.g., without substantial risk of dislodging the stent 40 from the ostium 90 and/or branch 94 .
- the locator loop 50 may contact the distal end 64 of the guide catheter 60 and be resiliently compressed as the delivery catheter 12 is pulled into the lumen 66 .
- the locator loop 50 may be elongated, narrowed, and/or otherwise directed inwardly towards the surface of the distal end 16 of the delivery catheter 12 as the locator loop 50 is drawn into the lumen 66 of the guide catheter 60 . If the struts 54 of the locator loop 50 are rounded or are inclined distally and/or transversely, they may facilitate pulling the locator loop 50 into the guide catheter 60 .
- FIG. 3 an alternative embodiment of a delivery catheter 12 ′ is shown that includes a pair of locator loops 50 .
- the locator loops 50 ′ may be formed from a wire, e.g., one or more strands of metal, plastic, or composite material that may be deformed elastically or superelastically in a contracted condition (nor shown) and resiliently expanded to an expanded condition, as shown.
- the intermediate regions 56 ′ of the locator loops 50 ′ extend partially around the delivery catheter 12 ,′ thereby generally defining a portion of a circle or ellipse “E” about the longitudinal axis 20 of the delivery catheter 12 .
- the locator loops 50 ′ may define an acute angle “ ⁇ ” between the intermediate region 56 ′ and the longitudinal axis 20 ′ towards the balloon 22 .′
- a delivery catheter 12 ′′ is shown that includes three locator loops 50 ′′ that include intermediate regions 56 ′′ that generally define a portion of a circle or ellipse “E” about the longitudinal axis 20 .′′ It will be appreciated that more than three locator loops (not shown) may be provided, if desired, that are disposed on one side of a delivery catheter.
- a plurality of locator loops may be provided asymmetrically about the longitudinal axis 20 ′′ of the delivery catheter 12 ,′′ e.g., such that the locator loops 50 ′′ only define a portion of a circle or ellipse “E” about the longitudinal axis 20 .′′
- One advantage of providing multiple locator loops on a delivery catheter is that multiple loops may distribute forces on the ostium more evenly, e.g., reducing the risk of perforation, skiving, or other damage of the wall of the ostium if the delivery catheter is pushed too forcefully.
- FIGS. 11 and 12 one of the advantages that may be achieved using a delivery catheter 12 including one or more locator loops 50 disposed on one side of a delivery catheter is now described.
- a single locator loop 50 is shown that extends transversely from one side of the delivery catheter 12 (although additional locator loops, not shown, may be disposed adjacent the single locator loop 50 shown).
- additional locator loops not shown, may be disposed adjacent the single locator loop 50 shown.
- the locator loop 50 may automatically turn the delivery catheter 12 about the longitudinal axis 20 to place the locator loop 50 on the outside bend radius of the delivery catheter 12 . This may occur naturally, e.g., in order to reduce the stress on the locator loop 50 .
- the locator loop 50 may be directed against the ostium 90 on the outside bend radius.
- the relative location of the locator loop 50 and the stent balloon 22 may be predetermined to position the stent (not shown) within the ostium 90 and/or branch 94 , as desired.
- the locator loop 50 a ′′′ on the inside bend radius may contact a portion of the ostium 90 before the locator loop 50 b ′′′ on the outside bend radius does.
- a user may feel resistance to further distal advancement in an inconsistent manner. This may reduce the accuracy in determining the location of the ostium 90 , i.e., providing the user tactile feedback before the stent 40 (not shown) on the balloon 22 ′′′ is actually positioned desirably within the branch 94 .
- the user may feel resistance to further advancement early, and may deploy the stent too proximally due to feeling this early resistance.
- a plurality of locator loops 50 a may be provided on a delivery catheter 12 a that are disposed substantially symmetrically about longitudinal axis 20 a .
- three locator loops 50 a are provided, e.g., offset approximately one hundred twenty degrees (120°) from one another.
- two, four, or more locator loops may be provided about the delivery catheter.
- one advantage of a plurality of symmetrically disposed locator loops 50 a is that the locator loops 50 a may contact the mouth of an ostium earlier, preventing any of the locator loops from at least partially entering the ostium.
- FIGS. 16A-24C several alternative embodiments of locators are shown that may be provided on a delivery catheter, e.g., including a single locator loop (such as those shown in FIGS. 16A-19C and 21 A- 22 C), or including a plurality of locator loops (such as those shown in FIGS. 20A-20C and 23 A- 24 C). It will be appreciated that any of these configurations may be provided on any of the apparatus described herein individually or in sets disposed symmetrically or asymmetrically on a delivery catheter.
- a locator loop 50 b that includes struts 54 b that curve outwardly from ends 52 b to intermediate region 56 b , which defines an acute angle with the longitudinal axis 20 b of the delivery catheter 12 b .
- the intermediate region 56 b includes a pointed and/or bent tip 58 b , e.g., disposed substantially at a midpoint of the wire defining the locator loop 50 b and/or intermediate region 56 b .
- the intermediate region 56 b generally defines a planar surface, and the bent tip 58 b extends transversely from this planar surface.
- the bent tip 58 b may define an acute, substantially perpendicular, or oblique angle relative to the planar surface and/or longitudinal axis 20 b .
- Such a bent tip 58 b may reduce the risk of the locator loop 50 b entering an ostium during deployment, e.g., by directing an axial force from distal advancement of the delivery catheter 12 b radially outwardly away from the ostium.
- a locator loop 50 c is shown that includes an intermediate region 56 c that defines an oblique angle with the longitudinal axis 20 c of the delivery catheter 12 c .
- the struts 54 c may curve more dramatically, i.e., extending distally and transversely relative to the longitudinal axis 20 c to more quickly deploy upon being exposed within a body lumen. This may reduce the risk of the locator loop 50 c being advanced into an ostium before the locator loop 50 c has opened completely.
- a locator loop 50 d is shown that includes ends 52 d fixed to delivery catheter 12 d , struts 54 d that extend axially initially and then bend away from one another, and a curved intermediate region 56 d extending between the struts 54 d .
- the locator loop 50 d may define a substantially “D” shape, e.g., defining a generally planar surface between the intermediate region 56 d and portions of the struts 54 d . This shape may allow the locator loop 50 d to distance itself more quickly from the delivery catheter 12 d upon deployment.
- the distal and transverse angle of the struts 54 d may enhance tactile feedback and/or facilitate withdrawal of the locator loop 50 d back into a guide catheter or other sheath (not shown).
- FIGS. 19A-19C a variation of the locator loop 50 d ′ of FIGS. 18A-18C is shown in which the struts 54 d ′ include a longer axial portion. This configuration may allow the locator loop 50 d ′ to extend at least partially over the stent and/or stent balloon (not shown for simplicity). The longer struts 54 d ′ may also cause the locator loop 50 d ′ to position the stent more proximally within an ostium, i.e., closer to the trunk than the branch.
- FIGS. 20 A- 20 C another variation is shown including a pair of locator loops 50 d ,′′ similar to the locator loop 50 d shown in FIGS. 18A-18C , disposed on opposite sides of a delivery catheter 12 d.′′
- a locator loop 50 e that includes relatively long struts 54 e that extend from fixed ends 52 e to a relatively short radius intermediate region 56 e .
- the locator loop 50 e may have a flower petal or “banana peel” shape, which may define a curved surface, as shown, or a substantially planar surface (not shown).
- the struts 54 e define a radius of curvature between about ninety and one hundred eighty degrees (90-180°), e.g., close to one hundred eighty degrees (180°), which may reduce the risk of the locator loop 50 e being directed into an ostium as the locator loop 50 e is deployed.
- the struts 54 e ′ may define a radius of curvature greater than one hundred eighty degrees (180°), e.g., approaching two hundred seventy degrees (270°). This configuration may further reduce the risk of the locator loop 50 e ′ being accidentally directed into an ostium during deployment.
- two, three, or more such locator loops 50 e may be provided on a delivery catheter 12 e , as shown in FIGS. 23A-24C .
- a locator loop 50 f may be provided on a delivery catheter 12 f that is twisted asymmetrically relative to the longitudinal axis 20 f of the delivery catheter 12 f .
- the surface defined by the locator loop 50 f defines a normal axis that does not extend substantially parallel to the longitudinal axis 20 f .
- one strut 54 f 1 may initially extend more axially than the other strut 54 f 2 such that the intermediate region 56 f defines an angle that intersects the longitudinal axis 20 f at a non-orthogonal angle (i.e., other than ninety degrees (90°)).
- the locator loop 50 g may include multiple wires wound around each other that are arranged asymmetrically. Similarly, a multiple wire locator may be provided for any of the embodiments described herein.
- the locator loop 50 h may include one strut 54 h 1 that is longer than the other strut 54 h 2 , thereby causing the intermediate region 56 h to be disposed non-orthogonally with respect to the longitudinal axis 20 h of the delivery catheter 12 h .
- the delivery catheter may include two ( FIGS. 28A-28C ), three ( FIGS. 29A-29C ), or optionally more (not shown) such locator loops.
- the locator loop(s) may have a tendency to “twist” relative to the longitudinal axis of the delivery catheter.
- FIGS. 30A-30D a method is shown for deploying a delivery catheter 12 f including one or more locator loops having an axial twist (one locator loop 50 f shown).
- the locator loop 50 f may be disposed within a guide catheter 60 (or other sheath, not shown).
- the locator loop 50 f may be oriented within the distal end 64 of the guide catheter 60 such that the apex or intermediate region 56 f of the locator loop 50 f is disposed along the inside radius of the distal end 64 .
- This location imposes the lowest stress on the locator loop 50 f , e.g., being closer to its deployed, enlarged configuration. Consequently, as shown in FIG. 30B , as the intermediate region 56 f of the locator loop 50 f first emerges from the guide catheter 60 , the locator loop 50 f is generally located along the inside radius of the guide catheter 60 .
- the locator loop 50 f may bear against the guide catheter 60 , causing the locator loop 50 f (and consequently, the distal end of the delivery catheter 12 f ) to twist or rotate about the longitudinal axis 20 f .
- the locator loop 50 f may have rotated substantially, e.g., by at least about sixty degrees (60°) about the longitudinal axis 20 f , relative to its initial position shown in FIG. 30B .
- FIGS. 31A-31D a method for using the locator loop 50 f to locate and position the delivery catheter 12 f relative to an ostium 90 is now described.
- the locator loop 50 f initially deploys along the inside radius of the guide catheter 60 , as described above. Because of the relative small initial size of the locator loop 50 f as it first emerges, there is a risk that the locator loop 50 f may enter the ostium along with the stent and/or stent balloon (not shown for simplicity).
- FIG. 31 A the locator loop 50 f initially deploys along the inside radius of the guide catheter 60 , as described above. Because of the relative small initial size of the locator loop 50 f as it first emerges, there is a risk that the locator loop 50 f may enter the ostium along with the stent and/or stent balloon (not shown for simplicity).
- FIG. 31 A the locator loop 50 f initially deploys along the inside radius of the guide catheter 60 , as described above. Because of the relative small initial
- FIGS. 58A-58F are additional perspective views of the delivery catheter 12 f being advanced from the guide catheter 60 . As the distal end is being advanced, a locator loop 50 f is shown emerging from an interior of the curve defined by the guide catheter 60 ( FIG. 58B ).
- the locator loop 50 f ′ automatically rotates around the longitudinal axis, e.g., up to one hundred eighty degrees (180°) ( FIGS. 58C-58F ), due to the stress stored in the locator loop 50 f when it is constrained within the guide catheter 60 .
- the locator loop 50 f may be fully deployed in contact with the wall adjacent the ostium 90 .
- the delivery catheter 12 f may then be advanced into the ostium 90 until the locator loop 50 f resists further advancement, thereby providing tactile feedback to the user that the stent may be positioned at the desired implantation site within the ostium 90 and/or branch, as described above.
- FIG. 32 another embodiment of a delivery catheter 112 is shown that includes a distal end 116 carrying a locator loop 150 and a balloon 122 for delivering a stent (not shown).
- the delivery catheter 112 and/or balloon 122 may be constructed and used similar to other embodiments described herein.
- the locator loop 150 includes ends 152 attached to the distal end 116 of the delivery catheter 112 , and a plurality of struts or spokes 154 extending from the ends 152 to curved outer loop regions 156 .
- the struts 154 are offset from one another approximately one hundred twenty degrees (120°) about a longitudinal axis 120 of the delivery catheter 112 , and are biased to extend distally and transversely, e.g., to define an acute angle with the longitudinal axis 120 .
- the outer loop regions 156 extend between adjacent struts 154 , thereby generally defining a circle or ellipse around the longitudinal axis 120 .
- the locator loop 150 may be formed from multiple segments of wire, with each segment defining a first end, a first strut, a curved region to a second strut, and a second end.
- the locator loop 150 may include three wire segments.
- the adjacent struts 154 may be at least partially attached to one another, e.g., by bonding, sonic welding, fusing the struts 154 , and/or winding the struts 154 around one another.
- adjacent struts 154 may be coupled at least partially to one another, for example, by disposing the adjacent struts 154 within a common tubular structure.
- the tubular structure may extend the full length of the struts 154 or may extend only partially, e.g., adjacent a base of the struts 154 . Attaching adjacent struts 154 to one another may increase a rigidity of the struts 154 compared to the loop regions 156 . Optionally, only a portion of the adjacent struts 154 may be attached to one another, e.g., immediately adjacent the ends 152 .
- the locator loop may include more than three wire segments (not shown), e.g., four, five, six, or more segments, although increasing the number of segments may increase the relative rigidity of the locator loop.
- the locator loop 150 may be cut or otherwise formed from a single section of tubing.
- the struts 154 may include single spokes (rather than adjacent struts) offset about the longitudinal axis 120 , and curved regions 156 extending between the spokes 154 .
- the locator loop 150 may be a unitary frame including a circular or elliptical portion defined by the curved regions 156 , and a plurality of spokes that couple the locator loop 150 to the delivery catheter 112 .
- the locator loop 150 may be formed by laser cutting, mechanically cutting, etching, or otherwise removing material from a tube to create the frame.
- Exemplary materials for the locator loop 150 include elastic or superelastic materials, such as Nitinol (NiTi), stainless steel, a polymer or other plastic, or other materials described elsewhere herein.
- the material of the locator loop 150 may be heat treated, e.g., to bias the frame to adopt the enlarged condition shown in FIG. 32 , yet allow the locator loop 150 to be radially compressed to a contracted condition (not shown) for delivery.
- the distal end 116 of the delivery catheter 112 may be loaded into a guide catheter (not shown) with the locator loop 150 constrained in a contracted condition using an introducer device (not shown).
- the locator loop 150 may be compressed and placed within a tubular member or other introducer device that is small enough to be received in the proximal end of the guide catheter.
- the introducer device may be removed, and the delivery catheter 112 advanced through the guide catheter, similar to the methods described above.
- the locator loop 150 When the distal end 116 of the delivery catheter 112 is deployed from the guide catheter, the locator loop 150 may resiliently spring open and assume the enlarged condition shown in FIG. 32 . As the distal end 116 of the delivery catheter 112 is advanced into an ostium (not shown) of a vessel to be treated, the locator loop 150 may contact the wall of the main body lumen or trunk surrounding the ostium, and prevent further movement, similar to the methods described elsewhere herein. Once the stent (not shown) is properly located using the locator loop 150 , the stent may be expanded or otherwise delivered, as described elsewhere herein. The delivery catheter 112 may then be withdrawn into the guide catheter or sheath, causing the locator loop 150 to collapse as it enters the guide catheter. The entire apparatus may then be removed from the patient.
- FIGS. 33A-33C an alternative embodiment of a delivery catheter 112 ′ is shown that includes a balloon 122 ′ (or multiple balloons, not shown) and a locator loop 150 ′ on a distal end 116 ′ of the delivery catheter 112 .
- the locator loop 150 ′ includes a plurality of struts or spokes 154 ′ extending between ends 152 ′ and curved regions 156 ,′ similar to the previous embodiment.
- the locator loop 150 ′ includes a plurality of supports 158 ′ that extend between the struts 154 .
- the supports 158 ′ enhance a rigidity of the struts 154 ′ between the connection point of the supports 158 ′ and the ends 152 ′ attached to the delivery catheter 112 .
- the struts 154 ′ may be divided into a deflectable outer portion 154 a ′ and a relatively rigid inner portion 154 b .′
- the location where the supports 158 ′ connect to the struts 154 ′ may correspond to a maximum inflation diameter of the balloon 122 .′
- the supports 158 ′ may generally define a diameter that is larger than a branch body vessel or ostium into which the delivery catheter 112 ′ may be directed, as explained further below.
- FIGS. 34A-34F a method is shown for implanting a stent 40 using the delivery catheter 112 ′ of FIGS. 33A-33C .
- a guidewire 98 and guide catheter 60 may be placed in a main body lumen 92 and/or extending through an ostium 90 into a branch body lumen 94 , which may include a lesion 96 , similar to the other embodiments described elsewhere herein.
- FIG. 34A a guidewire 98 and guide catheter 60 may be placed in a main body lumen 92 and/or extending through an ostium 90 into a branch body lumen 94 , which may include a lesion 96 , similar to the other embodiments described elsewhere herein.
- FIG. 34A a guidewire 98 and guide catheter 60 may be placed in a main body lumen 92 and/or extending through an ostium 90 into a branch body lumen 94 , which may include a lesion 96 , similar to the other embodiments described elsewhere herein.
- the distal end 116 ′ of the delivery catheter 112 ′ may be advanced into the main body lumen 92 , e.g., through the guide catheter 60 (or other sheath, not shown).
- the locator loop 150 ′ may expand to its enlarged condition as shown (and similar to that shown in FIGS. 33A-33C ).
- the distal end 116 ′ of the delivery catheter 116 ′ may be advanced over the guidewire 98 into the ostium 90 , e.g., until the balloon 122 ′ (and stent 40 carried thereon, not shown for clarity) is disposed adjacent the lesion 96 and/or within the branch 94 . As shown in FIG. 34B , the curved region 156 ′ of the locator loop 150 ′ may contact the wall of the main body lumen 92 surrounding the ostium 90 , thereby providing tactile feedback to the user.
- the locator loop 150 ′ has a relatively shallow length, i.e., transitions more quickly from the main body lumen 92 to the branch 94 .
- the balloon 122 ′ and stent may be located closer to the main body lumen 92 within the ostium 90 . Because of the predetermined relationship of the locator loop 150 ′ to the balloon 122 ,′ the stent may be positioned far enough into the ostium 90 without extending into the main body lumen 92 .
- FIG. 34C the ostium has a relatively shallow length, i.e., transitions more quickly from the main body lumen 92 to the branch 94 .
- the balloon 122 ′ and stent may be located closer to the main body lumen 92 within the ostium 90 . Because of the predetermined relationship of the locator loop 150 ′ to the balloon 122 ,′ the stent may be positioned far enough into the ostium 90 without extending into the main body lumen 92 .
- FIG. 34C the
- the ostium 90 ′ has a longer, more gradual transition between the main body lumen 92 ′ and the branch 94 .′ Because of this larger transition, the locator loop 150 ′ may be received deeper in the ostium 90 , positioning the balloon 122 ′ (and stent) deeper in the ostium 90 .′ Thus, the size and/or shape of the locator loop 150 ′ may automatically position the stent at a desired depth into an ostium even if the size and/or shape of the particular ostium encountered varies.
- the distal end 116 ′ of the delivery catheter 112 ′ may be advanced further into the ostium 90 and/or branch 94 . This distal force causes the locator loop 150 ′ to flex or bend, as shown in FIG. 34E .
- the struts 154 ′ may be bend in the outer portion 154 a ′ away from the ostium 90 , causing the curved regions 156 ′ to remain stationary, while the distal end 116 ′ of the delivery catheter 112 ′ enters further into the ostium 90 .
- additional tactile feedback will be provided to the user, indicating that the delivery catheter 112 ′ should not (and cannot) be advanced further. This feedback informs the user (and may be confirmed using fluoroscopy or other external imaging, as described elsewhere herein) that the stent 40 is now in an appropriate position for deployment.
- the balloon 122 ′ may then be inflated to expand the stent 40 within the ostium 90 and/or branch 94 , e.g., to dilate or otherwise treat the lesion 96 .
- the balloon 122 ′ may be deflated, and the distal end 116 ′ retracted into the guide catheter 60 (not shown) or otherwise removed from the patient, similar to methods described elsewhere herein.
- FIG. 35 another embodiment of a locator loop 250 is shown that may be formed from a section of tubing, e.g., from Nitinol or other material.
- the locator loop 250 includes a collar 252 from which struts 254 extend to outer loop portions 256 , generally similar to previous embodiments.
- the outer loop portions 256 may be biased to expand to the enlarged condition shown in FIG. 35 , but may be compressed or otherwise provided initially in a contracted condition.
- the locator loop 250 may include distinct sections cut or otherwise formed along a length of the tube 259 to provide the different regions of the locator loop 250 .
- one end of the tube 259 may be formed into the collar 252 , which may include a plurality of cells or other structure allowing the collar 252 to be crimped or otherwise secured onto a delivery catheter (not shown).
- the collar 252 may be a solid walled band that may be fitted around or otherwise to the delivery catheter.
- the collar 252 may be eliminated and ends of the struts 254 may be attached directly to the delivery catheter, similar to embodiments described elsewhere herein.
- Each strut 254 may include an inner portion 254 b coupled to the collar 252 and an outer portion 254 a coupled to the outer loop portions 256 .
- the inner portion 254 b may have a wider width than the outer portion 254 a and/or may have a greater thickness (not shown) such that the inner portion 254 b has a higher resistance to bending than the outer portion 254 a .
- the inner portion 254 b may provide a relatively stiff spoke portion, while the outer portion 254 a provides a relatively flexible spoke portion.
- the struts 254 When a bending moment is applied to the struts 254 , e.g., when the locator loop 250 is directed against an ostium, as described above, the struts 254 may preferentially bend at the transition between the inner and outer portions 254 b , 254 a . Thus, the locator loop 250 may respond and provide tactile feedback similar to the embodiments described above.
- the outer loop portions 256 may be formed from the end of the tube 259 opposite the collar 252 .
- the outer loop portions 256 may be formed as a plurality of serpentine elements that extend around a circumference of the tube between adjacent struts 254 .
- the outer loop portions 256 include a pair of straight sections 256 a extending from adjacent struts 254 and a loop 256 b extending between the straight sections 256 a .
- multiple loops may be provided between adjacent struts to provide outer loop portions 256 that expand in a desired manner.
- the tube may be expanded and treated, e.g., heat set, to program the flared, enlarged condition of the locator loop 250 , as shown in FIG. 35 .
- the tube may be formed from a shape memory material, e.g., Nitinol, such that the tube may be heat set to the enlarged condition in an austenitic state, and cooled to a martensitic state where the locator loop 250 may be plastically deformed back into the contracted condition.
- a shape memory material e.g., Nitinol
- the locator loop 250 when the locator loop 250 is heated, e.g., to body temperature within a patient, the locator loop 250 may transition back to its austenitic state, whereupon the locator loop 250 may be biased to return to the enlarged condition when deployed, as described above.
- the locator loop 250 ′ Before or after heat treatment, the locator loop 250 ′ may be cleaned or otherwise treated, e.g., using electro-polishing, abrasive blasting, and/or pickling.
- FIG. 36B an alternative embodiment of a locator loop 250 ′ is shown that includes a collar 252 ′, a plurality of struts 254 ,′ and a plurality of outer loop portions 256 ′ similar to the previous embodiment.
- the locator loop 250 ′ may include a plurality of loops 258 ′ that extend between adjacent struts 256 ,′ e.g., at the transitions between the inner and outer portions 254 b , 254 a of the struts 254 .′
- the loops 258 ′ may at least partially straighten to provide supports between the struts 254 ,′ thereby reinforcing the inner portions 254 b from bending when the locator loop 250 ′ is directed against an ostium.
- the loops 258 ′ may become transverse supports, similar to the struts 158 ′ shown in FIGS. 33A-33C and described elsewhere herein.
- FIG. 36C yet another embodiment of a locator loop 250 ′′ is shown that includes a collar 252 ,′′ a plurality of struts 254 ,′′ and an outer loop portion 256 .
- the struts 254 ′′ may include more flexible outer portions 254 a ′′ and more rigid inner portions 254 b .
- the inner portions 254 b ′′ have portions removed to increase their flexibility, which may desired in some applications.
- by several parameters may be adjusted to modify the rigidity of the struts 254 ′′ in a desired manner, e.g., their width, thickness, internal openings, and the like.
- FIG. 37 yet another embodiment of a locator loop 350 is shown that includes a portion formed from a tube 359 , and a portion formed from one or more wires 355 .
- the locator loop 350 includes a collar 352 and inner portions 354 b of struts formed from the tube 359 , similar to the previous embodiments.
- Outer portions 354 a of the struts and the outer loop portions may be formed from the one or more wires 355 , e.g., similar to any of the wire loop embodiments described elsewhere herein.
- the ends of the wires 355 may be attached to the tube 359 , for example, by weaving the wires 355 into one or more holes formed in the tube 359 .
- the wires 355 may be further secured to the tube 359 by welding, bonding, crimping, and the like.
- the wires 355 may be formed from drawn and filled tubes (“DFTs”), which may be a composite of a Nitinol outer tubular wire and a core of radiopaque material (e.g., gold, platinum, iridium, and the like). DFT wire may provide radiopacity without adding bulky elements to the locator loop.
- DFTs drawn and filled tubes
- a wire may have a smoother, more uniform profile along its length, which may allow higher strength and/or minimal post-processing (i.e., electro-polishing, sandblasting, etc.).
- a wire may have a microstructure where the metal grains are oriented along the length of the wire.
- cutting portions of the locator loop from a tube e.g., the outer loop portions, the tube may be cut at angles that are not parallel to the grain structure, which may result in grain orientation that is irregular and/or may weaken the resulting locator loop.
- loops cut from a tube require the loops to be folded or bent, which may increase localized stresses, which may result in failure or other damage to the locator loop during use.
- laser cut tubing may allow the collar to have a relatively small profile.
- a separate tube or other structure may be provided as a base to which the struts may be attached, but such a structure may be constructed less accurately, as compared to a laser cut collar.
- a section of heat shrink tubing may be used to secured struts to the underlying catheter, although the heat shrink tubing may have less strength than a metal or other laser cut collar.
- laser cut tubing may provide increased flexibility, i.e., allowing the various components, struts, collar, and loop portions, to be changed to meet desired mechanical and/or other performance criteria.
- radiopaque wire may be attached to inner portions 454 b ⁇ 1 of struts 454 b of a locator loop 450 b .
- radiopaque wire may be wrapped around the outer loop portions 456 c of a locator loop 450 c and/or around the outer portions 454 c ⁇ 2 of the struts 454 c .
- FIG. 38B radiopaque wire may be attached to inner portions 454 b ⁇ 1 of struts 454 b of a locator loop 450 b .
- radiopaque wire may be wrapped around the outer loop portions 456 c of a locator loop 450 c and/or around the outer portions 454 c ⁇ 2 of the struts 454 c .
- FIG. 38B radiopaque wire may be attached to inner portions 454 b ⁇ 1 of struts 454 b of a locator loop 450 b .
- FIG. 38C radiopaque wire may be wrapped around
- a radiopaque tube may be threaded or otherwise secured over a strut on inner support portions 454 d ⁇ 1 of the struts 454 d of a locator loop 454 d .
- These alternatives may be constructed and used similar to other embodiments described elsewhere herein.
- any of these embodiments for adding radiopacity may be included in any of the embodiments of locator loops or other structures described herein.
- FIGS. 39A and 39B another embodiment of an apparatus 510 is shown that includes a delivery catheter 512 including a distal end 516 carrying a stent 40 on a balloon 522 , similar to previous embodiments.
- the apparatus 510 includes a locator device 550 including a pair of locator arms 552 , each arm 552 including a fixed end attached to the distal end 516 of the delivery catheter 512 and a free end 554 .
- the locator arms 552 may be biased to an axial or contracted condition, such as that shown in FIG. 39A .
- the locator device 550 may include an actuator, e.g., a balloon 556 disposed on the distal end 516 of the delivery catheter 512 . When the balloon 556 is inflated, the locator arms 552 may be deflected radially outwardly to an enlarged condition, such as that shown in FIG. 39B .
- the delivery catheter 512 may be introduced into a trunk adjacent a branch with the locator arms 552 in the contracted condition shown in FIG. 39A , e.g., similar to the methods described elsewhere herein.
- the locator arms 552 may be expanded, as shown in FIG. 39B (e.g., after being advanced from a guide catheter, not shown), whereupon the distal end 516 of the delivery catheter 512 may be advanced into an ostium communicating with the branch.
- tactile feedback may be provided to the user, indicating that the stent 40 may be positioned within the ostium and/or branch.
- the stent may be deployed, similar to the other embodiments described herein, e.g., in a substantially uniform cylindrical configuration, such as that shown in FIG. 40B , in a tapered configuration, such as that shown in FIG. 40A , or in a flared configuration, such as that shown in FIG. 40C .
- the balloon 522 may be deflated, and the distal end 516 of the delivery catheter 512 withdrawn into a guide catheter or other sheath (not shown).
- the balloon 556 may be deflated, whereupon the locator arms 552 may resiliently resume the contracted condition, allowing the locator arms 552 to be withdrawn into the guide catheter.
- the locator arms 552 may be compressed towards the contracted condition when the distal end 516 of the delivery catheter 512 is withdrawn into the guide catheter, similar to the other embodiments described herein.
- FIGS. 41-44B show various embodiments of substantially atraumatic tips that may be provided on the ends 554 of the locator arms 552 shown in FIGS. 39A and 39B , or in other embodiments of locator devices described herein.
- FIG. 41 shows a tip of a locator arm 552 including a free end 554 that includes a toe 560 , a heel 562 , and a pair of torsion bars 564 .
- the toe 560 may hit first and cause a torque to be applied to the torsion bars 564 .
- the torsion bars 564 may then bend in response to this load and the heel 562 and toe 560 may rotate relative to the rest of the locator arm 552 . The rotation may continue until the heel 562 and toe 560 are parallel to the surface of the object making contact.
- the area of the heel 562 , toe 560 , and portions of the torsion bars 564 that contact the object may be relatively large relative compared to the to the force being applied, and therefore may be substantially atraumatic to the object being contacted.
- FIGS. 42A and 42B show another exemplary embodiment of an atraumatic tip 554 a that may be provided on a locator arm 552 a .
- the locator arm 552 a may be cut so that it has a tapered portion 566 a on its free end.
- a coil 568 a may then be placed over the tapered portion 566 a , e.g., in a similar fashion as a guidewire tip, and may be soldered, welded, and/or bonded in place.
- the coil 568 a may be provide an enlarged and/or resiliently deformable tip 554 a , which may reduce the risk of perforation or other damage to a vessel wall contacted by the tip 554 a.
- FIGS. 52A-52C show other alternative atraumatic tips that may be provided on locator arms described herein.
- FIG. 52A shows an atraumatic tip 554 d that may be provided on a locator arm 552 d .
- the tip 554 d may be formed by bending and/or curving the free end of the locator arm 552 d , e.g., such that the tip 554 d conforms substantially to the radius catheter (not shown) to which the locator arm 552 d is attached.
- the tip 554 d may extend around a portion of the circumference of the catheter while the locator arm 552 d extends along a length of the catheter, which may minimize a profile of the locator arm 552 d in the contracted condition.
- an atraumatic tip 554 e may be provided on a locator arm 552 e that includes an enlarged tab 567 e .
- the tab 567 e may include a hole or recess 569 e (shown in phantom), which may be filled with a radiopaque material, if desired, to facilitate monitoring the locator arm 552 e using fluoroscopy or other external imaging.
- an atraumatic tip 554 f may be provided on a locator arm 552 f that includes a pair of curved legs 570 f .
- the legs 570 f may include a radius corresponding to a radius of a catheter (not shown) to which the locator arm 552 f is attached, e.g., to minimize a profile of the locator arm 552 f in the contracted condition.
- any of these features may be combined, e.g., provided together on a free end of a locator arm, such as including a tab on a curved leg (not shown).
- FIGS. 43A-43D show another embodiment of an atraumatic tip 554 b for a locator arm 552 b .
- the locator arm 552 b may include three moveable members 572 b , 574 b and one static member 573 b , which may be attached to a catheter or may simulate a surface on a delivery catheter (not shown) to which the members 572 b are attached.
- the distal most member 574 b may rotate into a vertical orientation.
- the distal most locator arm 574 b may be substantially parallel to that surface in the configuration shown in FIG. 43D , providing maximum surface area for atraumatic contact.
- FIGS. 44A and 44B an additional embodiment is shown for an atraumatic tip 554 c for a locator arm 552 c .
- a free end of the locator arm 552 c may include a set of concentric loops 576 c cut into the end of it.
- These loops 576 c may be constructed, e.g., by thinning the loops 576 c , so that the loops 576 c are substantially flexible, e.g., may deform elastically or plastically when they come in contact with the patient's vasculature.
- 44B shows the atraumatic tip 554 c being deflected after contacting a wall of a trunk surrounding an ostium (not shown). As can be seen, the loops 576 c have deformed in response to the applied loads. This deformation prevents a large point load from being applied, and causing trauma to the patient.
- FIGS. 45A-45F show an exemplary embodiment of a locator device provided on a guide catheter 1010 for locating and positioning the guide catheter 1010 relative to an ostium.
- the guide catheter may be constructed similar to the embodiments described elsewhere herein. Once properly positioned, the guide catheter may be used to deliver a stent 40 using a separate stent delivery catheter, such as those described in application Ser. No. 11/136,266, incorporated by reference above.
- FIGS. 46A-48B show alternative embodiments of an expandable mesh or braid locator device that is expanded using an underlying balloon.
- FIGS. 50A and 50B show a plurality of splines or arms that may be expanded using an underlying balloon to provide a locator device. Any of these embodiments may be provided on a guide catheter or other tubular member. The guide catheter may then be used to locate and/or position the guide catheter adjacent an ostium, e.g., for delivering a stent into the ostium.
- FIGS. 49A, 49B , 51 A and 52 B show embodiments of a locator device including a plurality of expandable arms or splines that are expanded by retracting an overlying sheath.
- the arms may be biased to extend outwardly when the sheath is retracted ( FIGS. 49A and 49B ) or may be actuated to expand using the sheath ( FIGS. 51A and 51B ).
- FIGS. 53A-54B show various embodiments of locator devices that include a braided mesh that may be compressed axially to cause the braid to buckle and expand radially outwardly.
- FIGS. 55A and 55B show a locator device including a plurality of splines or arms that may be unwound to expand and wound to contract.
- FIGS. 56A and 56B show a plurality of arms that may be preferentially buckled to expand radially outwardly to provide a locator device.
- FIGS. 57A-57C show a plurality of wires or arms that may be deployed from a guide catheter.
- the arms may be biased to curve or evert back on themselves, e.g., until they engage a receiver on the guide catheter, thereby providing a locator device.
- locator devices may be provided on a stent delivery catheter, guide catheter, or other device that may be introduced into a patient's body, e.g., using the methods described elsewhere herein.
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Abstract
Apparatus and methods are provided for locating an ostium of a body lumen. In one embodiment, a delivery catheter or other tubular member includes a distal end sized for introduction into a body lumen, and one or more locator loops on the distal end. In one embodiment, the locator loop may include first and second ends fixed to the distal end, first and second resilient struts extending from the first and second ends, respectively, and a curved intermediate region extending between the first and second struts. The loop may be resiliently compressible to a contracted condition for delivery and resiliently expandable to an enlarged condition when deployed. The apparatus may include one or more balloons, stents, and the like on the distal end adjacent the locator loop.
Description
- This application claims benefit of provisional application Ser. No. 60/683,931, filed May 23, 2005, the entire disclosure of which is expressly incorporated by reference herein.
- The present invention relates generally to apparatus and methods for locating an ostium of a blood vessel or other body lumen, and, more particularly, to apparatus and methods for locating an ostium of a blood vessel or other body lumen to deliver a stent or other prosthesis into or adjacent the ostium.
- Tubular endoprosthesis or “stents” have been suggested for dilating or otherwise treating stenoses, occlusions, and/or other lesions within a patient's vasculature or other body lumens. For example, a self-expanding stent may be maintained on a catheter in a contracted condition, e.g., by an overlying sheath or other constraint, and delivered into a target location, e.g., a stenosis within a blood vessel or other body lumen. When the stent is positioned at the target location, the constraint may be removed, whereupon the stent may automatically expand to dilate or otherwise line the vessel at the target location. Alternatively, a balloon-expandable stent may be carried on a catheter, e.g., crimped or otherwise secured over a balloon, in a contracted condition. When the stent is positioned at the target location, the balloon may be inflated to expand the stent and dilate the vessel.
- Sometimes, a stenosis or other lesion may occur at an ostium or bifurcation, i.e., where a branch vessel extends from a main vessel. For example, such a lesion may form within a coronary artery immediately adjacent the aortic root. U.S. Pat. No. 5,749,890 to Shaknovich discloses a stent delivery assembly for placing a stent in an ostial lesion. U.S. Pat. No. 5,632,762 to Myler discloses a tapered balloon on a catheter for positioning a stent within an ostium. U.S. Pat. No. 5,607,444 to Lam discloses an expandable ostial stent including a tubular body and a deformable flaring portion. Published application US 2002/0077691 to Nachtigall discloses a delivery system that includes a sheath for holding a stent in a compressed state during delivery and a retainer that holds a deployable stop in an undeployed position while the delivery system is advanced to a desired location.
- Accordingly, apparatus and methods for locating an ostium and/or for delivering a stent within an ostium would be useful.
- The present invention is directed to apparatus and methods for locating a branch body lumen extending from a main body lumen, and, more particularly, to apparatus and methods for locating an ostium or bifurcation of a blood vessel or other body lumen, e.g., for delivering a stent or other prosthesis within or adjacent the ostium and/or for accessing the blood vessel.
- In accordance with one embodiment, an apparatus is provided that includes a tubular member including proximal and distal ends, and a lumen extending between the proximal and distal ends, an elongate member including a distal portion disposed within the lumen such that the distal portion may be advanced beyond the tubular member distal end, an expandable locator on the distal portion. In one embodiment, the locator includes a loop including first and second ends fixed to the distal portion, first and second resilient struts extending from the first and second ends, respectively, and a curved intermediate region extending between the first and second struts. The loop may be resiliently compressible to a contracted condition when the distal portion is disposed within the lumen and resiliently expandable to an enlarged condition when the distal portion is advanced beyond the tubular member distal end.
- In an exemplary embodiment, the loop may substantially define a plane in the enlarged condition and/or the plane may define an acute angle with a longitudinal axis of the tubular member. In another embodiment, the loop may be twisted asymmetrically relative to a longitudinal axis of the tubular member in the enlarged condition.
- In alternative embodiments, only a single loop or a plurality of expandable loops may be provided on the distal portion of the tubular member. If a plurality of expandable loops are provided, the loops may be disposed symmetrically or asymmetrically around a circumference of the tubular member. In one embodiment, the plurality of expandable loops may include curved intermediate regions that generally define a portion of an ellipse surrounding the distal portion.
- In accordance with another embodiment, an apparatus is provided for locating an ostium of a body lumen. Generally, the apparatus includes an elongate member including a distal portion that may advanced through a guide catheter or other tubular member, and a plurality of expandable loops on the distal portion. Each loop may include first and second resilient struts extending from the distal portion, and a curved intermediate region extending between the first and second struts. In addition or alternatively, each loop may be resiliently compressible to a contracted condition when the distal portion is disposed within the tubular member and resiliently expandable to an enlarged condition when the distal portion is advanced from the tubular member.
- In one embodiment, the loops may be disposed around the distal portion such that the intermediate regions define at least a portion of an ellipse surrounding the distal portion when the loops are in the enlarged condition. In addition or alternatively, the struts may be resiliently deflectable when the loops are expanded to the enlarged condition to provide tactile feedback when one or more of the intermediate regions contact an ostium.
- Optionally, a tubular prosthesis may be provided on the distal portion, e.g., adjacent the loops such that the apparatus may be used to position the prosthesis within an ostium.
- In accordance with still another embodiment, an apparatus is provided for locating an ostium of a body lumen that includes a tubular member including a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion. One or more locator elements may be disposed asymmetrically on the distal portion, each locator element including a first end fixed to the distal portion and a second end free from the distal portion. Each locator element may be resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device, and each locator element being resiliently expandable to an enlarged condition when fully deployed from the delivery device.
- Optionally, a stent or other prosthesis may be disposed on the distal portion.
- In accordance with yet another embodiment, an apparatus is provided for locating an ostium of a body lumen that includes a tubular member including a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion, and a locator loop on the distal portion. The locator loop may be resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device and/or resiliently expandable to an enlarged condition when fully deployed from the delivery device.
- In one embodiment, the locator loop may include a loop that substantially surrounds the distal portion of the tubular member in the enlarged condition, and a plurality of struts extending between the loop and the distal portion for attaching the locator loop to the tubular member. Optionally, the struts may include an inner portion closer to the tubular member and an outer portion closer to the loop, the inner portion being more rigid than the outer portion. In addition or alternatively, one or more supports may extend between adjacent struts at intermediate regions of the struts.
- In another embodiment, the locator loop may include a base attached to the distal portion of the tubular member, the struts extending from the base. Optionally, at least the base and the struts may be formed from a unitary tubular body. Optionally, the loop may also be formed from the unitary tubular body, or the loop may be formed from one or more wires attached to the unitary tubular body.
- In accordance with still another embodiment, a method is provided for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen. A distal end of a delivery catheter may be advanced into the main body lumen, the distal end including one or more locator elements constrained in a contracted condition. The one or more locator elements may be released within the main body lumen and directed against a wall of the ostium, and a procedure may be performed at or within the ostium based upon the position of the one or more locator elements in the enlarged condition, e.g., a stent may be delivered into the ostium.
- In one embodiment, the one or more locator elements may assume an asymmetrical orientation upon being released and/or may cause the distal end of the delivery catheter to rotate about its longitudinal axis when the locator elements are released.
- In addition or alternatively, the one or more locator elements may provide tactile feedback resisting further advancement when the one or more locator elements contact the main body lumen wall adjacent the ostium.
- In accordance with still another embodiment, a method is provided for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen. A distal end of a delivery catheter may be advanced into the main body lumen, and one or more locator elements on the distal end may be released within the main body lumen, the one or more locator elements resiliently expanding to substantially surround the distal end. The one or more locator elements may be directed against a wall of the ostium, thereby causing one or more struts supporting the one or more locator elements to bend away from the ostium. A procedure, e.g., stent delivery, may then be performed at or within the ostium based upon the position of the one or more locator elements in the enlarged condition.
- Other aspects and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
- The drawings illustrate exemplary embodiments of the invention, in which:
-
FIG. 1 is a perspective view of an apparatus for delivering a stent, including a guide catheter and a delivery catheter, the delivery catheter having a distal end carrying a locator loop adjacent a balloon over which a stent is maintained. -
FIG. 2 is a cross-sectional view of the catheter ofFIG. 1 , taken along line 2-2, with the locator loop expanded. -
FIGS. 3 and 4 are cross-sectional views of alternate embodiments of delivery catheters including multiple locator loops. -
FIGS. 5-10 are cross-sectional views of a patient's body, showing a method for implanting a stent within an ostium of a body lumen using the apparatus ofFIG. 1 . -
FIGS. 11 and 12 are cross-sectional views of a patient's body, comparing a method for locating an ostium using locator loops that are disposed around a circumference of a delivery catheter with a method using one or more locator loops that are disposed on only one side of a circumference of a delivery catheter. -
FIGS. 13A-13C are side, perspective, and ends views, respectively, of a locator including a single locator loop expanded transversely from a delivery catheter. -
FIGS. 14A-14C are side, perspective, and ends views, respectively, of a locator including a pair of locator loops adjacent on another on one side of a delivery catheter. -
FIGS. 15A-15C are perspective, and ends views, respectively, of a locator including three locator loops disposed symmetrically around a circumference of a delivery catheter. -
FIGS. 16A-16C are side, perspective, and ends views, respectively, of another locator including a single locator loop having a curved tip and expanded transversely from a delivery catheter. -
FIGS. 17A-17C are side, perspective, and ends views, respectively, of yet another locator including a single locator loop expanded transversely from a delivery catheter. -
FIGS. 18A-18C are side, perspective, and ends views, respectively, of another locator including a “D” shaped locator loop expanded transversely from a delivery catheter. -
FIGS. 19A-19C are side, perspective, and ends views, respectively, of still another locator including a “D” shaped locator loop extending transversely from a leg attached to a delivery catheter. -
FIGS. 20A-20C are side, perspective, and ends views, respectively, of yet another locator including a pair of “D” shaped locator loops expanded transversely from a delivery catheter. -
FIGS. 21A-21C are side, perspective, and ends views, respectively, of another locator including a narrow, curved locator loop expanded transversely from a delivery catheter. -
FIGS. 22A-22C are side, perspective, and ends views, respectively, of yet another locator including a narrow, curved locator loop expanded transversely from a delivery catheter. -
FIGS. 23A-23C are side, perspective, and ends views, respectively, of another locator including a pair of narrow, curved locator loop expanded transversely from a delivery catheter. -
FIGS. 24A-24C are side, perspective, and ends views, respectively, of another locator including three narrow, curved locator loop expanded transversely from a delivery catheter. -
FIGS. 25A-25C are side, perspective, and ends views, respectively, of a locator including a locator loop expanded transversely and asymmetrically from a delivery catheter. -
FIGS. 26A-26C are side, perspective, and ends views, respectively, of another locator including a locator loop expanded transversely and asymmetrically from a delivery catheter. -
FIGS. 27A-27C are side, perspective, and ends views, respectively, of still another locator including a locator loop expanded transversely and asymmetrically from a delivery catheter. -
FIGS. 28A-28C are side, perspective, and ends views, respectively, of a locator including a pair of locator loops expanded transversely and asymmetrically from a delivery catheter. -
FIGS. 29A-29C are side, perspective, and ends views, respectively, of a locator including three locator loops expanded transversely and asymmetrically from a delivery catheter. -
FIGS. 30A-30D are perspective views of a locator loop being deployed from a guide catheter, the locator loop automatically rotating about a longitudinal axis during deployment. -
FIGS. 31A-31D are perspective views of a locator loop being deployed from a guide catheter as the apparatus is advanced into an ostium. -
FIG. 32 is a perspective view of another embodiment of a delivery catheter including an expandable frame adjacent a stent balloon, with the frame expanded to provide a locator loop. -
FIG. 33A is a perspective view of yet another embodiment of a delivery catheter including an expandable frame adjacent a stent balloon, with the frame expanded to provide a locator loop. -
FIG. 33B is a perspective detail of the frame of the delivery catheter ofFIG. 33A . -
FIG. 33C is an end view detail of the frame of the delivery catheter ofFIG. 33A . -
FIGS. 34A-34F are cross-sectional views of a patient's body, showing a method for implanting a stent using the delivery catheter ofFIG. 32 . -
FIG. 35 is a perspective view of an expanded locator loop that may be provided on a delivery catheter. -
FIGS. 36A-36C are top views of alternate patterns that may be cut from a tube to provide the locator loop ofFIG. 35 , the pattern being shown flat for clarity. -
FIG. 37 is a top view of another pattern including a portion cut from a tube and a wire portion used to provide the locator loop ofFIG. 35 , the pattern being shown flat for clarity. -
FIGS. 38A-38D are top views of additional patterns that may be cut from a tube to provide the locator loop ofFIG. 35 , the pattern being shown flat for clarity. -
FIGS. 39A and 39B are side views of another embodiment of a stent delivery catheter including a plurality of locator arms adjacent the stent that are movable between collapsed and expanded configurations, respectively. -
FIGS. 40A-40C are details of the stent delivery catheter ofFIGS. 39A and 39B , showing different balloon and stent configurations that may be provided. -
FIG. 41 is a detail of a tip that may be provided on ends of the locator arms of the delivery catheter ofFIGS. 39A and 39B . -
FIGS. 42A and 42B are details of alternative tips that may be provided on ends of the locator arms of the delivery catheter ofFIGS. 39A and 39B . -
FIGS. 43A-43D are side views of another locator arm configuration that may be provided on a delivery catheter. -
FIGS. 44A and 44B are details of yet another tip that may be provided on ends of the locator arms of the delivery catheter ofFIGS. 39A and 39B . -
FIGS. 45A-45F are cross-sectional views of a patient's body, showing a method for implanting a stent in an ostium using a locator device including a balloon on a guide catheter. -
FIGS. 46A and 46B are side views of another embodiment of a locator device including a balloon-expandable braid on a guide catheter movable between collapsed and expanded configurations, respectively. -
FIG. 47 is a side view of an alternate embodiment of the locator device ofFIGS. 46B . -
FIGS. 48A and 48B are cross-sectional views of a patient's body, showing a method for accessing an ostium using the locator device ofFIG. 47 . -
FIGS. 49A and 49B are side views of another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by retracting an overlying sheath. -
FIGS. 50A and 50B are side views of another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by inflating an underlying balloon. -
FIGS. 51A and 51B are side views of yet another embodiment of a locator device including a plurality of arms on a guide catheter that are movable between collapsed and expanded configurations, respectively, by retracting an overlying sheath. -
FIG. 51C is a detail of the locator device ofFIGS. 51A and 51B , showing an exemplary arm extending through a slit in the sheath. -
FIGS. 52A-52C are details showing alternate tips that may be provided on the arms of the locator devices shown inFIGS. 49A-51C . -
FIGS. 53A and 53B are side views of yet another embodiment of a locator device including an expandable braid on a guide catheter that is movable between collapsed and expanded configurations, respectively. -
FIGS. 54A and 54B are cross-sectional details, showing alternative constructions for a tip of the locator device ofFIGS. 53A and 53B . -
FIGS. 55A and 55B are side views of still another embodiment of a locator device including a plurality of expandable splines on a guide catheter that are movable between collapsed and expanded configurations, respectively. -
FIGS. 56A and 56B are side views of yet another embodiment of a locator device including a plurality of expandable splines or arms on a guide catheter that are movable between collapsed and expanded configurations, respectively. -
FIGS. 57A-57C are side views of another embodiment of a locator device including a plurality of everting wires that are deployable from a guide catheter. -
FIGS. 58A-58F are perspective views of a locator loop being deployed from a guide catheter, the locator loop automatically rotating about a longitudinal axis during deployment. - Turning to the drawings,
FIG. 1 shows an exemplary embodiment of anapparatus 10 for delivering a stent orother prosthesis 40, e.g., into an ostium or other bifurcation between a main lumen and a branch lumen (not shown). Generally, theapparatus 10 includes a catheter or other elongatetubular member 12 having aproximal end 14, adistal end 16, and one ormore lumens 18 extending between the proximal and distal ends 14, 16, thereby defining alongitudinal axis 20 between the proximal and distal ends 14, 16. Thedelivery catheter 12 includes alocator loop 50 on thedistal end 16, e.g., proximal or otherwise adjacent to astent 40 also carried on thedistal end 16, which may be any of the locator loops described herein. Optionally, one or more balloons or otherexpandable members 22 may be provided on thedistal end 16 of thedelivery catheter 12 for expanding and/or deploying thestent 40, as described further below. - In addition, the
apparatus 10 may include aguide catheter 60 including aproximal end 62, adistal end 64, and alumen 66 extending therebetween. Thedistal end 64 may be sized and/or shaped to facilitate advancement into a patient's vasculature or other body lumen, as described further below. Thelumen 66 may have sufficient size for receiving thedistal end 16 of thedelivery catheter 12 therethrough, e.g., with thelocator loop 50 in a contracted condition, also as explained further below. Optionally, thedistal end 64 of theguide catheter 60 may be biased to a predetermined shape, e.g., a “J” shape, which may facilitate positioning theguide catheter 60 within or adjacent an ostium. Theguide catheter 60 may be constructed from substantially flexible and/or floppy materials, e.g., plastic having a braid or other reinforcement (not shown) that sufficiently supports theguide catheter 60 to prevent kinking or buckling, while allowing theguide catheter 60 to be directed easily through tortuous anatomy. Optionally, theapparatus 10 may include other components to provide a system or kit for delivering thestent 40, e.g., a sheath that may be advanced over and/or retracted from thedistal end 16 of thedelivery catheter 12, one or more syringes or other sources of inflation media and/or vacuum, tubing, and/or one or more guidewires (all not shown). - With continued reference to
FIG. 1 , thedelivery catheter 12 may be formed from one or more tubular bodies, e.g., having variable flexibility along its length. For example, thedistal end 16 may be substantially flexible to facilitate insertion through tortuous anatomy, e.g., terminating in a rounded, tapered, and/or other substantially atraumaticdistal tip 17. Thedistal end 16 may be sized and/or shaped for introduction into a body lumen, e.g., having a diameter between about one and seven millimeters (1-7 mm), or less than 1.5 millimeters. Theproximal end 14 may be substantially flexible or semi-rigid, e.g., having sufficient column strength to facilitate advancing thedistal end 16 through a patient's vasculature by pushing on theproximal end 14. Thedelivery catheter 12 may be formed from plastic, metal, or composite materials, e.g., a plastic material having a wire, braid, or coil core, which may preventing kinking or buckling of thecatheter 12 during advancement. - As shown in
FIG. 1 , thedelivery catheter 12 may include ahandle 30 on theproximal end 14, e.g., to facilitate manipulating thedelivery catheter 12. Thehandle 30 may include one or more side ports 32 communicating withrespective lumens 18 within thedelivery catheter 12. Thehandle 30 may be molded, machined, or otherwise formed from plastic, metal, or composite material, e.g., providing an outer casing, which may be contoured or otherwise shaped to ease manipulation. Theproximal end 14 of thedelivery catheter 12 may be attached to thehandle 30, e.g., by bonding, cooperating connectors, interference fit, and the like. Optionally, if the apparatus includes any actuatable components (not shown) on thedistal end 16, thehandle 30 may include one or more actuators (not shown), such as one or more slides, dials, buttons, and the like, for actuating or otherwise manipulating the components on thedistal end 16 from theproximal end 14, as explained further below. - In the embodiment shown in
FIG. 1 , thedelivery catheter 12 includes at least twolumens 18 extending between the proximal ends 14, 16. For example, thedelivery catheter 12 may include a guidewire or instrument lumen that extends from a port 32 a in thehandle 30 to anopening 34 in thedistal tip 17. The instrument lumen may have sufficient size to allow a guidewire or other rail or instrument (not shown) to be inserted therethrough, e.g., to facilitate advancing thedelivery catheter 12 over the rail, as explained further below. Optionally, thehandle 30 may include one or more seals (not shown) within or adjacent the port 32 a, e.g., e.g., a hemostatic seal that prevents fluid, e.g., blood, from flowing proximally out of the port 32 a, yet allows one or more instruments to be inserted therethrough and into the instrument lumen. - In addition, the
delivery catheter 12 may include one or more inflation lumens that extend from respective side port(s) 32 b in thehandle 30 through thedelivery catheter 12 to openings (not shown) that communicate with an interior of arespective balloon 22. The side port(s) 32 b on thehandle 30 may include connectors, e.g., a luer lock connector (not shown), one or more seals (also not shown), and the like. A source of inflation media and/or vacuum, e.g., a syringe filled with saline (not shown), may be connected to the side port(s) 32 b, e.g., via tubing (also not shown), for expanding and/or collapsing theballoon 22. - As shown in
FIG. 1 , thedelivery catheter 12 includes oneballoon 22 on thedistal end 16. Alternatively, thedelivery catheter 12 may include multiple balloons (not shown) on thedistal end 16 over which thestent 40 may be placed. Additional information on multiple balloon catheters and methods for using them are disclosed in co-pending application Ser. No. 11/136,266, filed May 23, 2005, and provisional application Ser. No. 60/745,177, filed Apr. 19, 2006. The entire disclosures of these references are expressly incorporated by reference herein. - The balloon (or balloons, not shown) 22 may be bonded or otherwise secured to the
distal end 16 of thedelivery catheter 12. For example, ends of theballoon 22 may be attached to thedistal end 16 using one or more of bonding with an adhesive, sonic welding, an annular collar or sleeve, and the like. Theballoon 22 may be expandable from a contracted condition (not shown, see, e.g.,FIG. 6 ), which may facilitate advancement through a patient's vasculature, to an enlarged condition for expanding or otherwise deploying thestent 40. - The
balloon 22 may be formed from substantially inelastic material, e.g., PET, nylon, or PEBAX, such that theballoon 22 expands to a predetermined size in its enlarged condition once sufficient fluid is introduced into the interior of theballoon 22. Alternatively, theballoon 22 may be formed from substantially elastic material, e.g., silicone, polyurethane, or polyethylene, such that theballoon 22 may be expanded to a variety of sizes depending upon the volume and/or pressure of fluid within the interior. - The
stent 40 may be formed from a variety of materials that may be plastically deformed to allow expansion of thestent 40. For example, thestent 40 may be formed from metal, such as stainless steel, tantalum, MP35N, Niobium, Nitinol, and L605, plastic, or composite materials. In particular, the materials of thestent 40 may be plastically deformed under the pressures experienced when theballoon 22 is expanded such that all or one or more portions of thestent 40 are deformed beyond their elastic limit. Thus, when theballoon 22 is subsequently collapsed, thestent 40 may maintain its expanded configuration with minimal recoil. For example, thestent 40 material may resist collapsing back towards its reduced configuration if the tissue surrounding the body lumen attempts to constrict or otherwise return to its occluded shape. - Alternatively, at least a portion of the
stent 40 may be self-expanding. For example, thestent 40 may be biased to expand at least partially outwardly yet may be constrained over theballoon 22 in a contracted condition to facilitate delivery, e.g., using a sheath, filament, and the like (not shown). In this alternative, thestent 40 may be formed from Nitinol or other shape memory or superelastic materials. Optionally, the resistance of thestent 40 to expansion may be varied along its length. This performance of thestent 40 may be based upon mechanical properties of the material, e.g., which may involve heat treating one or more portions of thestent 40 differently than other portions. In addition or alternatively, the structure of thestent 40 may be varied, e.g., by providing struts, fibers, or other components in different portions having different widths, thicknesses, geometry, and the like. - The
stent 40 may be a generally tubular structure, e.g., including openings in a tubular wall that facilitate expansion of thestent 40 and/or allow tissue ingrowth. For example, the stent may be an elongate tube that has slots or other openings formed in the tube wall, e.g., by laser cutting, mechanical cutting, chemical etching, machining, and the like. Alternatively, thestent 40 may be a braided or other structure, e.g., formed from one or wires or other filaments braided or otherwise wound in a desired manner. Additional possible stent structures may include helical coil wires or sheets. If desired, one or more portions of thestent 40 may include a membrane, film, or coating (not shown), e.g., to create a nonporous, partially porous, or porous surface between cells of thestent 40 and/or to carry one or more therapeutic compounds. Additional information on stents that may be delivered using thecatheter 12 may be found in co-pending application Ser. No. 60/683,920, filed May 23, 2005, 60/710,521, filed Aug. 22, 2005, 60/731,568, filed Oct. 28, 2005, 60/757,600, filed Jan. 9, 2006, 60/743,880, filed Mar. 28, 2006, and 60/745,177, filed Apr. 19, 2006. The entire disclosures of these references are expressly incorporated by reference herein. - With additional reference to
FIGS. 13A-13C , in one embodiment, thelocator loop 50 is an expandable member including first and second ends 52 fixed to thedistal end 16 of thedelivery catheter 12, first and secondresilient struts 54 extending from the first and second ends 52, respectively, and a curvedintermediate region 56 extending between the first andsecond struts 54. Thelocator loop 50 may formed from a single strand extending from thefirst end 52, through the first struts 54, theintermediate region 56, and thesecond strut 54 to thesecond end 52. Alternatively, thelocator loop 50 may be formed from multiple strands that are wound about one another to form a braided or other structure. In another alternative, thelocator loop 50 may include different sections of material for one or more regions of thelocator loop 50 that are attached to one another, e.g., by bonding, melting, or fusing the ends, using connector bands, and the like (not shown). In yet another alternative, thelocator loop 50 may be formed from a tube that has portions removed, e.g., similar to the construction of thestent 40, as described further below. - The
locator loop 50 may be formed from an elastic or superelastic material, e.g., metal such as Nitinol, stainless steel, and the like, plastic, and/or composite materials (e.g., a metal wire core covered with a plastic coating). Thelocator loop 50 is generally resiliently compressible to a contracted condition, and biased to expand to an enlarged condition, such as that shown inFIGS. 13A-13C , when free from external forces. - For example, the
locator loop 50 may be compressed against thedistal end 16 of thedelivery catheter 12 and constrained in the contracted condition, e.g., when thedistal end 16 of thedelivery catheter 12 is loaded into thelumen 66 of theguide catheter 60. In this condition, thestruts 54 may extend substantially axially along thedistal end 16 and theintermediate region 56 may be partially straightened, twisted, or otherwise compressed towards the surface of thedistal end 16. Alternatively, a sheath (not shown) may be provided that extends over thedistal end 16 of thedelivery catheter 12 to constrain the locator loop 50 (and/or cover thestent 40 and balloon 22). When thedistal end 16 of thedelivery catheter 12 is advanced beyond thedistal end 64 of the guide catheter 60 (or the overlying sheath is retracted), thelocator loop 50 may resiliently expand to the enlarged condition. - The ends 52 of the
locator loop 50 may be attached or otherwise secured to thedistal end 16 of thedelivery catheter 12. For example, an adhesive, sonic welding, fusing, and the like may be used to bond the ends 52 to the surface of thedistal end 16. In addition or alternatively, a band of material, e.g., a heat shrink tube or other band of plastic, metal, wire, and the like, may be wrapped or otherwise extend around theends 52 of thelocator loop 50. In addition or alternatively, the ends 52 of thelocator loop 50 may be at least partially embedded into thedelivery catheter 12, e.g., into slots or holes partially or completely penetrating the wall of thedelivery catheter 12. In yet another alternative, the ends 52 may be part of an annular band that may crimped or otherwise secured around thedelivery catheter 12, e.g., in addition to or instead of the other attachment methods described above. - In the embodiment shown in
FIGS. 13A-13C , thestruts 54 are relatively short, and theintermediate region 56 is relatively long, although in some embodiments described herein, thestruts 54 may be substantially longer than theintermediate region 56. Theintermediate region 56 is generally curved, e.g., defining an arcuate shape approximating a portion of an ellipse or circle. Thus, theintermediate region 56 may generally define a surface, which may be substantially planar as shown inFIGS. 13A-13C or curved, as shown and described elsewhere herein. Alternatively, theintermediate region 56 may be biased to assume a more complicated curved geometry, as described further below. - The
struts 54 and/orintermediate region 56 may also be shaped such that theintermediate region 56 extends transversely relative to thelongitudinal axis 20 of thecatheter 12. For example, thestruts 54 may be curved or otherwise transition from an axial direction to a transverse direction. As shown, the ends 52 may extend substantially axially, while theintermediate region 56 extends substantially perpendicular to thelongitudinal axis 20. In alternative embodiments, such as those described elsewhere herein, theintermediate region 56 and/or other portions of thelocator loop 50 may extend laterally relative to thelongitudinal axis 20, e.g., defining an acute or oblique angle with thelongitudinal axis 20. - The
locator loop 50 may have sufficient strength (e.g., column strength and/or bending resistance) to be self-supporting, yet be at partially deflectable, e.g., to provide tactile feedback to a user, as explained further below. For example, one or more portions of thelocator loop 50, e.g., thestruts 54 and/orintermediate region 56, may bend or flex when thelocator loop 50 contacts and is pushed against a surface (e.g., a wall of a body lumen adjacent an ostium). The initial contact may provide a first tactile feedback, and thereafter resist further bending or flexing to provide a second or additional tactile feedback, as described further elsewhere herein. - Turning to
FIGS. 5-10 , an exemplary method is shown for using theapparatus 10 to deliver astent 40 into anostium 90. Theostium 90 may be an opening in a wall of a first or main body lumen ortrunk 92 that communicates with a second body lumen orbranch 94. In an exemplary embodiment, thetrunk 92 may be the aortic root and thebranch 94 may be a coronary artery. In another embodiment, thetrunk 92 may be the distal aorta, and thebranch 94 may a renal artery or other abdominal branch. It will be appreciated that the apparatus and methods described herein may be applicable to a variety of bifurcations or branches that extend transversely, e.g., laterally (for example, at relatively shallow angles) or substantially perpendicularly, from another body lumen or trunk, e.g., within a patient's vasculature or other systems. - An occlusion or
other lesion 96 may exist at and/or adjacent to theostium 90, e.g., extending at least partially into thebranch 94. Thelesion 96 may include atherosclerotic plaque or other material that partially or completely occludes blood or other fluid flow between thetrunk 92 and thebranch 94. - Initially, as shown in
FIG. 5 , aguidewire 98 or other rail may be introduced from thetrunk 92 through theostium 90 into thebranch 94. As shown, thelesion 96 at theostium 90 partially occludes theostium 90 and extends into thebranch 94. Theguidewire 98 may be placed using conventional methods. For example, a percutaneous puncture or cut-down may be created at a peripheral location (not shown), such as a femoral artery, carotid artery, or other entry site, and theguidewire 98 may be advanced through the patient's vasculature from the entry site, e.g., alone or with the aid ofguide catheter 60. If thelesion 96 completely occludes thebranch 94, theguidewire 98 may be directed through the occlusion or other devices (not shown) may be advanced over theguidewire 98 or otherwise in conjunction with theguidewire 98 to create a passage through thelesion 96 for theguidewire 98. - After the
guidewire 98 is directed into thebranch 94 beyond thelesion 96, it may be desirable to at least partially dilate thelesion 96. For example, an angioplasty catheter (not shown) may be advanced through theguide catheter 60 and/or over theguidewire 98 into and through thelesion 96, whereupon a balloon or other element on the catheter may be expanded to at least partially dilate thelesion 96. If desired, other procedures may also be performed at thelesion 96, e.g., to soften, remove, or otherwise treat plaque or other material forming thelesion 96, before thestent 40 is implanted. After completing any such procedures, instruments advanced over theguidewire 98 may be removed. - As shown in
FIG. 5 , thedistal end 64 of theguide catheter 60 may be advanced over theguidewire 98 into thetrunk 92, e.g., until thedistal end 64 is disposed adjacent or proximal to theostium 90. Theguide catheter 60 may be used to advance one or more instruments (such as those just described) over theguidewire 98 and into thetrunk 92 and/orbranch 94. - Turning to
FIG. 6 , adistal end 16 of thedelivery catheter 12 may be advanced over theguidewire 98 and through thelumen 66 of theguide catheter 60 from the entry site into thetrunk 92. As shown, thelocator loop 50,balloon 22, andstent 40 are carried in contracted conditions through theguide catheter 60. Although thelocator loop 50 may be biased to extend outwardly, theguide catheter 60 may allow thelocator loop 50 to slide freely within thelumen 66 while remaining in the contracted condition. Optionally, the locator loop 50 (and/or the guide catheter 60) may include a lubricious coating to reduce friction and/or otherwise facilitate advancement through theguide catheter 60. - Turning to
FIG. 7 , with thedistal end 16 of thedelivery catheter 12 within thetrunk 92, theguide catheter 60 may be withdrawn from theostium 90 to advance thedistal end 16 out of thelumen 66. As thelocator loop 50 is advanced out of theguide catheter 60, thelocator loop 50 may resiliently expand within thetrunk 92, as shown. Optionally, if a sheath overlies thelocator loop 50 and/orstent 40, the sheath may be retracted before or after deploying thedistal end 16 of thecatheter 12 from theguide catheter 60. In this position, thedistal tip 17 of thecatheter 12 may extend into theostium 90, as shown, or may be located within thetrunk 92. - Turning to
FIG. 8 , thedelivery catheter 12 may be advanced, thereby directing thedistal end 16 into theostium 90, e.g., such that thedistal tip 17 extends through thelesion 96 and into thebranch 94 beyond. As thedistal end 16 is advanced, thelocator loop 50 contacts and is pushed against the wall of thetrunk 92 surrounding or adjacent theostium 90. This initial contact may be transmitted back to the proximal end (not shown) of thedelivery catheter 12 due to the increased resistance to further advancement, thereby providing tactile feedback to the user of the location of thestent 40 relative to theostium 90. Thedelivery catheter 12 may be advanced further until thelocator loop 50 bends, as shown, thereby preventing further distal movement. This increased resistance provides further tactile feedback that thedistal end 16 of thedelivery catheter 12 is positioned at an appropriate location for deploying thestent 40. - For example, the relative location of the
locator loop 50 to thestent 40 on thedistal end 16 of thedelivery catheter 12 may be predetermined such that the position where further distal movement is impeded by thelocator loop 50 corresponds to the optimum distance into theostium 90 and/orbranch 94 for deploying thestent 40. Optionally, one or more radiopaque markers (not shown) may be provided, e.g., on one or both ends of thestent 40, on thecatheter 12 orballoon 22 under one or both ends of thestent 40, and/or on thelocator loop 50. In one embodiment, thelocator loop 50 may be made radiopaque through the incorporation of radiopaque materials in its construction, either as an integral part of the loop wire, or as a structure attached to the loop wire. Contrast may be delivered, e.g., via thedelivery catheter 12 or through the guide catheter 60 (e.g., after advancing theguide catheter 60 until thedistal end 64 contacts the ostium 90), to facilitate identifying the position of thestent 40 relative to theostium 90 under fluoroscopy or other external imaging. - Turning to
FIG. 9 , thestent 40 may then be deployed within theostium 90 and/orbranch 94. For example, if thedelivery catheter 12 includes asingle balloon 22, theballoon 22 may be inflated to expand thestent 40, e.g., within thebranch 94 immediately adjacent theostium 90 to dilate and/or otherwise treat thelesion 96. Theballoon 22 may expand thestent 40 to a substantially uniform cylindrical shape as shown inFIG. 9 . Alternatively, theballoon 22 may expand thestent 40 to a frusto-conical or other tapered shape, similar to that shown inFIG. 40A . - In a further alternative, the
delivery catheter 12 may include multiple balloons (not shown) under thestent 40 that may be used to expand portions of thestent 40 sequentially, as described in application Serial No. 11/136,266 or the other applications incorporated by reference above. For example, a proximal balloon (not shown) may be inflated to expand a proximal portion of thestent 40, e.g., into a flared configuration, adjacent thelocator loop 50. Thedelivery catheter 12 may be advanced distally, e.g., until the flared portion conforms or otherwise contacts the wall of thetrunk 92 surrounding theostium 90. Once the flared portion is seated, another balloon may be inflated to expand a distal portion of thestent 40 within thelesion 96 and/orbranch 94. - Turning to
FIG. 10 , once thestent 40 is expanded and/or positioned in a desired manner, the balloon(s) 22 may be collapsed, e.g., by evacuating the inflation media using a syringe or other device (not shown) at the proximal end (also not shown) of thedelivery catheter 12. With theballoon 22 collapsed, thedelivery catheter 12 may be withdrawn into theguide catheter 60. Optionally, theguide catheter 60 may be advanced towards or against theostium 90 and/or against a proximal end of thestent 40 before thedelivery catheter 12 is removed. This action may facilitate withdrawing the distal end 16 (e.g., the balloon 22) back through thestent 40, e.g., without substantial risk of dislodging thestent 40 from theostium 90 and/orbranch 94. - As the
distal end 16 of thedelivery catheter 12 is withdrawn into theguide catheter 60, thelocator loop 50 may contact thedistal end 64 of theguide catheter 60 and be resiliently compressed as thedelivery catheter 12 is pulled into thelumen 66. For example, thelocator loop 50 may be elongated, narrowed, and/or otherwise directed inwardly towards the surface of thedistal end 16 of thedelivery catheter 12 as thelocator loop 50 is drawn into thelumen 66 of theguide catheter 60. If thestruts 54 of thelocator loop 50 are rounded or are inclined distally and/or transversely, they may facilitate pulling thelocator loop 50 into theguide catheter 60. - Turning to
FIG. 3 (with additional reference toFIGS. 14A-14C ), an alternative embodiment of adelivery catheter 12′ is shown that includes a pair of locator loops 50.′ Similar to the previous embodiment, thelocator loops 50′ may be formed from a wire, e.g., one or more strands of metal, plastic, or composite material that may be deformed elastically or superelastically in a contracted condition (nor shown) and resiliently expanded to an expanded condition, as shown. Theintermediate regions 56′ of thelocator loops 50′ extend partially around thedelivery catheter 12,′ thereby generally defining a portion of a circle or ellipse “E” about thelongitudinal axis 20 of the delivery catheter 12.′ As shown inFIG. 14A , thelocator loops 50′ may define an acute angle “α” between theintermediate region 56′ and thelongitudinal axis 20′ towards the balloon 22.′ - In a further alternative, shown in
FIG. 4 , adelivery catheter 12″ is shown that includes threelocator loops 50″ that includeintermediate regions 56″ that generally define a portion of a circle or ellipse “E” about thelongitudinal axis 20.″ It will be appreciated that more than three locator loops (not shown) may be provided, if desired, that are disposed on one side of a delivery catheter. Stated differently, a plurality of locator loops may be provided asymmetrically about thelongitudinal axis 20″ of thedelivery catheter 12,″ e.g., such that thelocator loops 50″ only define a portion of a circle or ellipse “E” about thelongitudinal axis 20.″ One advantage of providing multiple locator loops on a delivery catheter is that multiple loops may distribute forces on the ostium more evenly, e.g., reducing the risk of perforation, skiving, or other damage of the wall of the ostium if the delivery catheter is pushed too forcefully. - Turning to
FIGS. 11 and 12 , one of the advantages that may be achieved using adelivery catheter 12 including one ormore locator loops 50 disposed on one side of a delivery catheter is now described. As shown inFIG. 11 , asingle locator loop 50 is shown that extends transversely from one side of the delivery catheter 12 (although additional locator loops, not shown, may be disposed adjacent thesingle locator loop 50 shown). When thedelivery catheter 12 is directed from thetrunk 92 into thebranch 94, there may be a substantial direction change, e.g., as much as ninety degrees (90°) or more. As thelocator loop 50 contacts theostium 90, thelocator loop 50 may automatically turn thedelivery catheter 12 about thelongitudinal axis 20 to place thelocator loop 50 on the outside bend radius of thedelivery catheter 12. This may occur naturally, e.g., in order to reduce the stress on thelocator loop 50. Thus, as thedistal end 16 of thedelivery catheter 12 is advanced into theostium 90, thelocator loop 50 may be directed against theostium 90 on the outside bend radius. The relative location of thelocator loop 50 and thestent balloon 22 may be predetermined to position the stent (not shown) within theostium 90 and/orbranch 94, as desired. - In contrast, in
FIG. 12 , where thedelivery catheter 12′″ includeslocator loops 50′″ on both sides, thelocator loop 50 a′″ on the inside bend radius may contact a portion of theostium 90 before thelocator loop 50 b′″ on the outside bend radius does. Thus, a user may feel resistance to further distal advancement in an inconsistent manner. This may reduce the accuracy in determining the location of theostium 90, i.e., providing the user tactile feedback before the stent 40 (not shown) on theballoon 22′″ is actually positioned desirably within thebranch 94. Thus, as shown inFIG. 12 , the user may feel resistance to further advancement early, and may deploy the stent too proximally due to feeling this early resistance. - Alternatively, turning to
FIGS. 15A-15B , a plurality oflocator loops 50 a may be provided on adelivery catheter 12 a that are disposed substantially symmetrically about longitudinal axis 20 a. As shown, threelocator loops 50 a are provided, e.g., offset approximately one hundred twenty degrees (120°) from one another. Alternatively, two, four, or more locator loops (not shown) may be provided about the delivery catheter. As described further below, one advantage of a plurality of symmetrically disposedlocator loops 50 a is that thelocator loops 50 a may contact the mouth of an ostium earlier, preventing any of the locator loops from at least partially entering the ostium. - Turning to
FIGS. 16A-24C , several alternative embodiments of locators are shown that may be provided on a delivery catheter, e.g., including a single locator loop (such as those shown inFIGS. 16A-19C and 21A-22C), or including a plurality of locator loops (such as those shown inFIGS. 20A-20C and 23A-24C). It will be appreciated that any of these configurations may be provided on any of the apparatus described herein individually or in sets disposed symmetrically or asymmetrically on a delivery catheter. - For example, turning to
FIGS. 16A-16C , alocator loop 50 b is shown that includesstruts 54 b that curve outwardly from ends 52 b tointermediate region 56 b, which defines an acute angle with thelongitudinal axis 20 b of the delivery catheter 12 b. Theintermediate region 56 b includes a pointed and/orbent tip 58 b, e.g., disposed substantially at a midpoint of the wire defining thelocator loop 50 b and/orintermediate region 56 b. Theintermediate region 56 b generally defines a planar surface, and thebent tip 58 b extends transversely from this planar surface. For example, thebent tip 58 b may define an acute, substantially perpendicular, or oblique angle relative to the planar surface and/orlongitudinal axis 20 b. Such abent tip 58 b may reduce the risk of thelocator loop 50 b entering an ostium during deployment, e.g., by directing an axial force from distal advancement of the delivery catheter 12 b radially outwardly away from the ostium. - Turning to
FIGS. 17A-17C , alocator loop 50 c is shown that includes anintermediate region 56 c that defines an oblique angle with thelongitudinal axis 20 c of thedelivery catheter 12 c. Thestruts 54 c may curve more dramatically, i.e., extending distally and transversely relative to thelongitudinal axis 20 c to more quickly deploy upon being exposed within a body lumen. This may reduce the risk of thelocator loop 50 c being advanced into an ostium before thelocator loop 50 c has opened completely. - Turning to
FIGS. 18A-18C , alocator loop 50 d is shown that includes ends 52 d fixed todelivery catheter 12 d, struts 54 d that extend axially initially and then bend away from one another, and a curvedintermediate region 56 d extending between thestruts 54 d. Thus, upon deployment, thelocator loop 50 d may define a substantially “D” shape, e.g., defining a generally planar surface between theintermediate region 56 d and portions of thestruts 54 d. This shape may allow thelocator loop 50 d to distance itself more quickly from thedelivery catheter 12 d upon deployment. The distal and transverse angle of thestruts 54 d (defining an acute angle with thelongitudinal axis 20 d) may enhance tactile feedback and/or facilitate withdrawal of thelocator loop 50 d back into a guide catheter or other sheath (not shown). - Turning to
FIGS. 19A-19C , a variation of thelocator loop 50 d′ ofFIGS. 18A-18C is shown in which thestruts 54 d′ include a longer axial portion. This configuration may allow thelocator loop 50 d′ to extend at least partially over the stent and/or stent balloon (not shown for simplicity). The longer struts 54 d′ may also cause thelocator loop 50 d′ to position the stent more proximally within an ostium, i.e., closer to the trunk than the branch. Turning to FIGS. 20A-20C, another variation is shown including a pair oflocator loops 50 d,″ similar to thelocator loop 50 d shown inFIGS. 18A-18C , disposed on opposite sides of adelivery catheter 12 d.″ - Turning to
FIGS. 21A-21C , alocator loop 50 e is shown that includes relatively long struts 54 e that extend from fixed ends 52 e to a relatively short radiusintermediate region 56 e. Thus, thelocator loop 50 e may have a flower petal or “banana peel” shape, which may define a curved surface, as shown, or a substantially planar surface (not shown). As shown, thestruts 54 e define a radius of curvature between about ninety and one hundred eighty degrees (90-180°), e.g., close to one hundred eighty degrees (180°), which may reduce the risk of thelocator loop 50 e being directed into an ostium as thelocator loop 50 e is deployed. - Optionally, as shown in
FIGS. 22A-22C , thestruts 54 e′ may define a radius of curvature greater than one hundred eighty degrees (180°), e.g., approaching two hundred seventy degrees (270°). This configuration may further reduce the risk of thelocator loop 50 e′ being accidentally directed into an ostium during deployment. In addition or alternatively, two, three, or moresuch locator loops 50 e may be provided on adelivery catheter 12 e, as shown inFIGS. 23A-24C . - Turning to
FIGS. 25A-25C , in another embodiment, alocator loop 50 f may be provided on adelivery catheter 12 f that is twisted asymmetrically relative to thelongitudinal axis 20 f of thedelivery catheter 12 f. Stated differently, unlike the previous embodiments, the surface defined by thelocator loop 50 f defines a normal axis that does not extend substantially parallel to thelongitudinal axis 20 f. Instead, as shown, one strut 54f 1 may initially extend more axially than the other strut 54f 2 such that theintermediate region 56 f defines an angle that intersects thelongitudinal axis 20 f at a non-orthogonal angle (i.e., other than ninety degrees (90°)). - In an alternative embodiment, shown in
FIGS. 26A-26C , thelocator loop 50 g may include multiple wires wound around each other that are arranged asymmetrically. Similarly, a multiple wire locator may be provided for any of the embodiments described herein. - In yet another alternative embodiment, shown in
FIGS. 27A-27C , thelocator loop 50 h may include one strut 54h 1 that is longer than the other strut 54h 2, thereby causing theintermediate region 56 h to be disposed non-orthogonally with respect to thelongitudinal axis 20 h of thedelivery catheter 12 h. In other variations, the delivery catheter may include two (FIGS. 28A-28C ), three (FIGS. 29A-29C ), or optionally more (not shown) such locator loops. Thus, in these variations, the locator loop(s) may have a tendency to “twist” relative to the longitudinal axis of the delivery catheter. - Turning to
FIGS. 30A-30D , with additional reference toFIGS. 25A-25C , a method is shown for deploying adelivery catheter 12 f including one or more locator loops having an axial twist (onelocator loop 50 f shown). Initially, with reference toFIG. 30A , thelocator loop 50 f may be disposed within a guide catheter 60 (or other sheath, not shown). Because of the bias of thelocator loop 50 f to expand radially outwardly (and/or because thedistal end 64 of theguide catheter 60 is generally biased into a curved shape), thelocator loop 50 f may be oriented within thedistal end 64 of theguide catheter 60 such that the apex orintermediate region 56 f of thelocator loop 50 f is disposed along the inside radius of thedistal end 64. This location imposes the lowest stress on thelocator loop 50 f, e.g., being closer to its deployed, enlarged configuration. Consequently, as shown inFIG. 30B , as theintermediate region 56 f of thelocator loop 50 f first emerges from theguide catheter 60, thelocator loop 50 f is generally located along the inside radius of theguide catheter 60. - Turning to
FIG. 30C , as thelocator loop 50 f is deployed further, the less axial, more curved strut of thelocator loop 50 f may bear against theguide catheter 60, causing thelocator loop 50 f (and consequently, the distal end of thedelivery catheter 12 f) to twist or rotate about thelongitudinal axis 20 f. As shown inFIG. 30D , once thelocator loop 50 f is fully deployed, thelocator loop 50 f may have rotated substantially, e.g., by at least about sixty degrees (60°) about thelongitudinal axis 20 f, relative to its initial position shown inFIG. 30B . - Turning to
FIGS. 31A-31D , a method for using thelocator loop 50 f to locate and position thedelivery catheter 12 f relative to anostium 90 is now described. InFIG. 31 A , thelocator loop 50 f initially deploys along the inside radius of theguide catheter 60, as described above. Because of the relative small initial size of thelocator loop 50 f as it first emerges, there is a risk that thelocator loop 50 f may enter the ostium along with the stent and/or stent balloon (not shown for simplicity). Turning toFIG. 31B , however, because of the bias of thelocator loop 50 f to twist axially, as thelocator loop 50 f is deployed further, thelocator loop 50 f (and consequentially the distal end of thedelivery catheter 12 f) may rotate about thelongitudinal axis 20 f of thedelivery catheter 12 f, thereby avoiding theostium 90.FIGS. 58A-58F are additional perspective views of thedelivery catheter 12 f being advanced from theguide catheter 60. As the distal end is being advanced, alocator loop 50 f is shown emerging from an interior of the curve defined by the guide catheter 60 (FIG. 58B ). As thelocator loop 50 f becomes fully exposed, thelocator loop 50 f′ automatically rotates around the longitudinal axis, e.g., up to one hundred eighty degrees (180°) (FIGS. 58C-58F ), due to the stress stored in thelocator loop 50 f when it is constrained within theguide catheter 60. - As shown in
FIG. 31C , once thelocator loop 50 f rotates around and past theostium 90, thelocator loop 50 f may be fully deployed in contact with the wall adjacent theostium 90. Turning toFIG. 31D , thedelivery catheter 12 f may then be advanced into theostium 90 until thelocator loop 50 f resists further advancement, thereby providing tactile feedback to the user that the stent may be positioned at the desired implantation site within theostium 90 and/or branch, as described above. - Turning to
FIG. 32 , another embodiment of adelivery catheter 112 is shown that includes adistal end 116 carrying alocator loop 150 and aballoon 122 for delivering a stent (not shown). Thedelivery catheter 112 and/orballoon 122 may be constructed and used similar to other embodiments described herein. Similar to the previous embodiments, thelocator loop 150 includesends 152 attached to thedistal end 116 of thedelivery catheter 112, and a plurality of struts orspokes 154 extending from theends 152 to curvedouter loop regions 156. As shown, thestruts 154 are offset from one another approximately one hundred twenty degrees (120°) about alongitudinal axis 120 of thedelivery catheter 112, and are biased to extend distally and transversely, e.g., to define an acute angle with thelongitudinal axis 120. Theouter loop regions 156 extend betweenadjacent struts 154, thereby generally defining a circle or ellipse around thelongitudinal axis 120. - In one embodiment, the
locator loop 150 may be formed from multiple segments of wire, with each segment defining a first end, a first strut, a curved region to a second strut, and a second end. Thus, in the embodiment shown inFIG. 32 , thelocator loop 150 may include three wire segments. Optionally, theadjacent struts 154 may be at least partially attached to one another, e.g., by bonding, sonic welding, fusing thestruts 154, and/or winding thestruts 154 around one another. In addition,adjacent struts 154 may be coupled at least partially to one another, for example, by disposing theadjacent struts 154 within a common tubular structure. The tubular structure may extend the full length of thestruts 154 or may extend only partially, e.g., adjacent a base of thestruts 154. Attachingadjacent struts 154 to one another may increase a rigidity of thestruts 154 compared to theloop regions 156. Optionally, only a portion of theadjacent struts 154 may be attached to one another, e.g., immediately adjacent the ends 152. Alternatively, the locator loop may include more than three wire segments (not shown), e.g., four, five, six, or more segments, although increasing the number of segments may increase the relative rigidity of the locator loop. - In another embodiment, the
locator loop 150 may be cut or otherwise formed from a single section of tubing. In this embodiment, thestruts 154 may include single spokes (rather than adjacent struts) offset about thelongitudinal axis 120, andcurved regions 156 extending between thespokes 154. Thus, thelocator loop 150 may be a unitary frame including a circular or elliptical portion defined by thecurved regions 156, and a plurality of spokes that couple thelocator loop 150 to thedelivery catheter 112. - The
locator loop 150 may be formed by laser cutting, mechanically cutting, etching, or otherwise removing material from a tube to create the frame. Exemplary materials for thelocator loop 150 include elastic or superelastic materials, such as Nitinol (NiTi), stainless steel, a polymer or other plastic, or other materials described elsewhere herein. Optionally, the material of thelocator loop 150 may be heat treated, e.g., to bias the frame to adopt the enlarged condition shown inFIG. 32 , yet allow thelocator loop 150 to be radially compressed to a contracted condition (not shown) for delivery. - During use, the
distal end 116 of thedelivery catheter 112 may be loaded into a guide catheter (not shown) with thelocator loop 150 constrained in a contracted condition using an introducer device (not shown). For example, after manufacturing or any time before use, thelocator loop 150 may be compressed and placed within a tubular member or other introducer device that is small enough to be received in the proximal end of the guide catheter. Once thedistal end 116 of thedelivery catheter 112 and thelocator loop 150 are positioned in the guide catheter, the introducer device may be removed, and thedelivery catheter 112 advanced through the guide catheter, similar to the methods described above. - When the
distal end 116 of thedelivery catheter 112 is deployed from the guide catheter, thelocator loop 150 may resiliently spring open and assume the enlarged condition shown inFIG. 32 . As thedistal end 116 of thedelivery catheter 112 is advanced into an ostium (not shown) of a vessel to be treated, thelocator loop 150 may contact the wall of the main body lumen or trunk surrounding the ostium, and prevent further movement, similar to the methods described elsewhere herein. Once the stent (not shown) is properly located using thelocator loop 150, the stent may be expanded or otherwise delivered, as described elsewhere herein. Thedelivery catheter 112 may then be withdrawn into the guide catheter or sheath, causing thelocator loop 150 to collapse as it enters the guide catheter. The entire apparatus may then be removed from the patient. - Turning to
FIGS. 33A-33C , an alternative embodiment of adelivery catheter 112′ is shown that includes aballoon 122′ (or multiple balloons, not shown) and alocator loop 150′ on adistal end 116′ of the delivery catheter 112.′ Thelocator loop 150′ includes a plurality of struts orspokes 154′ extending betweenends 152′ andcurved regions 156,′ similar to the previous embodiment. Unlike the previous embodiments, thelocator loop 150′ includes a plurality ofsupports 158′ that extend between the struts 154.′ The supports 158′ enhance a rigidity of thestruts 154′ between the connection point of thesupports 158′ and theends 152′ attached to the delivery catheter 112.′ Thus, thestruts 154′ may be divided into a deflectable outer portion 154 a′ and a relatively rigid inner portion 154 b .′ - As best seen in
FIG. 33C , the location where thesupports 158′ connect to thestruts 154′ may correspond to a maximum inflation diameter of the balloon 122.′ In addition or alternatively, thesupports 158′ may generally define a diameter that is larger than a branch body vessel or ostium into which thedelivery catheter 112′ may be directed, as explained further below. - Turning to
FIGS. 34A-34F , a method is shown for implanting astent 40 using thedelivery catheter 112′ ofFIGS. 33A-33C . Initially, as shown inFIG. 34A , aguidewire 98 and guidecatheter 60 may be placed in amain body lumen 92 and/or extending through anostium 90 into abranch body lumen 94, which may include alesion 96, similar to the other embodiments described elsewhere herein. Turning toFIG. 34B (where theguide catheter 60 has been omitted for clarity and/or withdrawn at least partially from the ostium 90), thedistal end 116′ of thedelivery catheter 112′ may be advanced into themain body lumen 92, e.g., through the guide catheter 60 (or other sheath, not shown). As thedistal end 116′ is deployed from the guide catheter 60 (or other sheath), thelocator loop 150′ may expand to its enlarged condition as shown (and similar to that shown inFIGS. 33A-33C ). - The
distal end 116′ of thedelivery catheter 116′ may be advanced over theguidewire 98 into theostium 90, e.g., until theballoon 122′ (andstent 40 carried thereon, not shown for clarity) is disposed adjacent thelesion 96 and/or within thebranch 94. As shown inFIG. 34B , thecurved region 156′ of thelocator loop 150′ may contact the wall of themain body lumen 92 surrounding theostium 90, thereby providing tactile feedback to the user. - One advantage of the
locator loop 150′ is shown inFIGS. 34C and 34D . For example, inFIG. 34C , the ostium has a relatively shallow length, i.e., transitions more quickly from themain body lumen 92 to thebranch 94. In this embodiment, theballoon 122′ and stent may be located closer to themain body lumen 92 within theostium 90. Because of the predetermined relationship of thelocator loop 150′ to theballoon 122,′ the stent may be positioned far enough into theostium 90 without extending into themain body lumen 92. In contrast, inFIG. 34D , theostium 90′ has a longer, more gradual transition between themain body lumen 92′ and the branch 94.′ Because of this larger transition, thelocator loop 150′ may be received deeper in theostium 90, positioning theballoon 122′ (and stent) deeper in the ostium 90.′ Thus, the size and/or shape of thelocator loop 150′ may automatically position the stent at a desired depth into an ostium even if the size and/or shape of the particular ostium encountered varies. - Returning to
FIG. 34B , after thelocator loop 150′ contacts the wall around theostium 90, thedistal end 116′ of thedelivery catheter 112′ may be advanced further into theostium 90 and/orbranch 94. This distal force causes thelocator loop 150′ to flex or bend, as shown inFIG. 34E . With additional reference toFIGS. 33A-33C , because of thesupports 158′ on thelocator loop 150,′ thestruts 154′ may be bend in the outer portion 154 a′ away from theostium 90, causing thecurved regions 156′ to remain stationary, while thedistal end 116′ of thedelivery catheter 112′ enters further into theostium 90. When thesupports 158′ and/or the ends of the inner portions 154 b′ of thestruts 154′ contact theostium 90, additional tactile feedback will be provided to the user, indicating that thedelivery catheter 112′ should not (and cannot) be advanced further. This feedback informs the user (and may be confirmed using fluoroscopy or other external imaging, as described elsewhere herein) that thestent 40 is now in an appropriate position for deployment. - Turning to
FIG. 34F , theballoon 122′ may then be inflated to expand thestent 40 within theostium 90 and/orbranch 94, e.g., to dilate or otherwise treat thelesion 96. Once thestent 40 is deployed, theballoon 122′ may be deflated, and thedistal end 116′ retracted into the guide catheter 60 (not shown) or otherwise removed from the patient, similar to methods described elsewhere herein. - Turning to
FIG. 35 , another embodiment of alocator loop 250 is shown that may be formed from a section of tubing, e.g., from Nitinol or other material. As shown, thelocator loop 250 includes acollar 252 from which struts 254 extend toouter loop portions 256, generally similar to previous embodiments. Theouter loop portions 256 may be biased to expand to the enlarged condition shown inFIG. 35 , but may be compressed or otherwise provided initially in a contracted condition. - With additional reference to
FIG. 36 , which shows atube 259 unrolled about its circumference, thelocator loop 250 may include distinct sections cut or otherwise formed along a length of thetube 259 to provide the different regions of thelocator loop 250. For example, one end of thetube 259 may be formed into thecollar 252, which may include a plurality of cells or other structure allowing thecollar 252 to be crimped or otherwise secured onto a delivery catheter (not shown). Alternatively, thecollar 252 may be a solid walled band that may be fitted around or otherwise to the delivery catheter. In a further alternative, thecollar 252 may be eliminated and ends of thestruts 254 may be attached directly to the delivery catheter, similar to embodiments described elsewhere herein. - An intermediate portion of the
tube 259 may be formed into thestruts 254, which extend generally axially when cut from thetube 259. Eachstrut 254 may include aninner portion 254 b coupled to thecollar 252 and anouter portion 254 a coupled to theouter loop portions 256. Theinner portion 254 b may have a wider width than theouter portion 254 a and/or may have a greater thickness (not shown) such that theinner portion 254 b has a higher resistance to bending than theouter portion 254 a. Stated differently, theinner portion 254 b may provide a relatively stiff spoke portion, while theouter portion 254 a provides a relatively flexible spoke portion. When a bending moment is applied to thestruts 254, e.g., when thelocator loop 250 is directed against an ostium, as described above, thestruts 254 may preferentially bend at the transition between the inner andouter portions locator loop 250 may respond and provide tactile feedback similar to the embodiments described above. - The
outer loop portions 256 may be formed from the end of thetube 259 opposite thecollar 252. Theouter loop portions 256 may be formed as a plurality of serpentine elements that extend around a circumference of the tube betweenadjacent struts 254. As shown, theouter loop portions 256 include a pair ofstraight sections 256 a extending fromadjacent struts 254 and aloop 256 b extending between thestraight sections 256 a. Alternatively, if desired, multiple loops (not shown) may be provided between adjacent struts to provideouter loop portions 256 that expand in a desired manner. - Once the
tube 259 is cut, e.g., into the pattern shown inFIG. 36A , the tube may be expanded and treated, e.g., heat set, to program the flared, enlarged condition of thelocator loop 250, as shown inFIG. 35 . Optionally, the tube may be formed from a shape memory material, e.g., Nitinol, such that the tube may be heat set to the enlarged condition in an austenitic state, and cooled to a martensitic state where thelocator loop 250 may be plastically deformed back into the contracted condition. Subsequently, when thelocator loop 250 is heated, e.g., to body temperature within a patient, thelocator loop 250 may transition back to its austenitic state, whereupon thelocator loop 250 may be biased to return to the enlarged condition when deployed, as described above. Before or after heat treatment, thelocator loop 250′ may be cleaned or otherwise treated, e.g., using electro-polishing, abrasive blasting, and/or pickling. - Turning to
FIG. 36B , an alternative embodiment of alocator loop 250′ is shown that includes acollar 252′, a plurality ofstruts 254,′ and a plurality ofouter loop portions 256′ similar to the previous embodiment. Unlike the previous embodiment, thelocator loop 250′ may include a plurality of loops 258′ that extend betweenadjacent struts 256,′ e.g., at the transitions between the inner andouter portions struts 254,′ thereby reinforcing theinner portions 254 b from bending when thelocator loop 250′ is directed against an ostium. Thus, the loops 258′ may become transverse supports, similar to thestruts 158′ shown inFIGS. 33A-33C and described elsewhere herein. - Turning to
FIG. 36C , yet another embodiment of alocator loop 250″ is shown that includes acollar 252,″ a plurality ofstruts 254,″ and anouter loop portion 256.″ Similar to the previous embodiments, thestruts 254″ may include more flexibleouter portions 254 a″ and more rigidinner portions 254 b.″ In this embodiment, theinner portions 254 b″ have portions removed to increase their flexibility, which may desired in some applications. Thus, by several parameters may be adjusted to modify the rigidity of thestruts 254″ in a desired manner, e.g., their width, thickness, internal openings, and the like. - Turning to
FIG. 37 , yet another embodiment of alocator loop 350 is shown that includes a portion formed from atube 359, and a portion formed from one ormore wires 355. As shown, thelocator loop 350 includes acollar 352 andinner portions 354 b of struts formed from thetube 359, similar to the previous embodiments.Outer portions 354 a of the struts and the outer loop portions (not shown) may be formed from the one ormore wires 355, e.g., similar to any of the wire loop embodiments described elsewhere herein. The ends of thewires 355 may be attached to thetube 359, for example, by weaving thewires 355 into one or more holes formed in thetube 359. In addition or alternatively, thewires 355 may be further secured to thetube 359 by welding, bonding, crimping, and the like. - Optionally, the
wires 355 may be formed from drawn and filled tubes (“DFTs”), which may be a composite of a Nitinol outer tubular wire and a core of radiopaque material (e.g., gold, platinum, iridium, and the like). DFT wire may provide radiopacity without adding bulky elements to the locator loop. - There may be several advantages of providing the outer loop portions and/or
outer portions 354 a of the struts from a wire structure. For example, a wire may have a smoother, more uniform profile along its length, which may allow higher strength and/or minimal post-processing (i.e., electro-polishing, sandblasting, etc.). In addition, a wire may have a microstructure where the metal grains are oriented along the length of the wire. In contrast, cutting portions of the locator loop from a tube, e.g., the outer loop portions, the tube may be cut at angles that are not parallel to the grain structure, which may result in grain orientation that is irregular and/or may weaken the resulting locator loop. In addition, loops cut from a tube require the loops to be folded or bent, which may increase localized stresses, which may result in failure or other damage to the locator loop during use. - However, laser cut tubing may allow the collar to have a relatively small profile. Alternatively, a separate tube or other structure may be provided as a base to which the struts may be attached, but such a structure may be constructed less accurately, as compared to a laser cut collar. For example, in an alternative embodiment, a section of heat shrink tubing may be used to secured struts to the underlying catheter, although the heat shrink tubing may have less strength than a metal or other laser cut collar. Further, laser cut tubing may provide increased flexibility, i.e., allowing the various components, struts, collar, and loop portions, to be changed to meet desired mechanical and/or other performance criteria.
- Turning to
FIGS. 38A-38D , variations of these locator loops are shown, which may include components intended to enhance radiopacity of the locator loop. For example, as shown inFIG. 38B , radiopaque wire may be attached toinner portions 454 b−1 ofstruts 454 b of alocator loop 450 b. Alternatively, as shown inFIG. 38C , radiopaque wire may be wrapped around the outer loop portions 456 c of a locator loop 450 c and/or around theouter portions 454 c−2 of thestruts 454 c. In a further alternative shown inFIG. 38D , a radiopaque tube may be threaded or otherwise secured over a strut oninner support portions 454 d−1 of thestruts 454 d of alocator loop 454 d. These alternatives may be constructed and used similar to other embodiments described elsewhere herein. In addition, any of these embodiments for adding radiopacity may be included in any of the embodiments of locator loops or other structures described herein. - Turning to
FIGS. 39A and 39B , another embodiment of anapparatus 510 is shown that includes adelivery catheter 512 including adistal end 516 carrying astent 40 on a balloon 522, similar to previous embodiments. In addition, theapparatus 510 includes alocator device 550 including a pair oflocator arms 552, eacharm 552 including a fixed end attached to thedistal end 516 of thedelivery catheter 512 and afree end 554. In the embodiment shown, thelocator arms 552 may be biased to an axial or contracted condition, such as that shown inFIG. 39A . Thelocator device 550 may include an actuator, e.g., aballoon 556 disposed on thedistal end 516 of thedelivery catheter 512. When theballoon 556 is inflated, thelocator arms 552 may be deflected radially outwardly to an enlarged condition, such as that shown inFIG. 39B . - During use, the
delivery catheter 512 may be introduced into a trunk adjacent a branch with thelocator arms 552 in the contracted condition shown inFIG. 39A , e.g., similar to the methods described elsewhere herein. Within the trunk, thelocator arms 552 may be expanded, as shown inFIG. 39B (e.g., after being advanced from a guide catheter, not shown), whereupon thedistal end 516 of thedelivery catheter 512 may be advanced into an ostium communicating with the branch. When the ends 554 of thelocator arms 552 contact the wall surrounding the ostium, tactile feedback may be provided to the user, indicating that thestent 40 may be positioned within the ostium and/or branch. The stent may be deployed, similar to the other embodiments described herein, e.g., in a substantially uniform cylindrical configuration, such as that shown inFIG. 40B , in a tapered configuration, such as that shown inFIG. 40A , or in a flared configuration, such as that shown inFIG. 40C . - Once the
stent 40 is expanded and/or otherwise deployed, the balloon 522 may be deflated, and thedistal end 516 of thedelivery catheter 512 withdrawn into a guide catheter or other sheath (not shown). Theballoon 556 may be deflated, whereupon thelocator arms 552 may resiliently resume the contracted condition, allowing thelocator arms 552 to be withdrawn into the guide catheter. Alternatively or in addition, thelocator arms 552 may be compressed towards the contracted condition when thedistal end 516 of thedelivery catheter 512 is withdrawn into the guide catheter, similar to the other embodiments described herein. -
FIGS. 41-44B show various embodiments of substantially atraumatic tips that may be provided on theends 554 of thelocator arms 552 shown inFIGS. 39A and 39B , or in other embodiments of locator devices described herein. - For example,
FIG. 41 shows a tip of alocator arm 552 including afree end 554 that includes atoe 560, aheel 562, and a pair of torsion bars 564. As thelocator arm 552 makes contact with an object (e.g., a wall of a vessel, not shown), thetoe 560 may hit first and cause a torque to be applied to the torsion bars 564. The torsion bars 564 may then bend in response to this load and theheel 562 andtoe 560 may rotate relative to the rest of thelocator arm 552. The rotation may continue until theheel 562 andtoe 560 are parallel to the surface of the object making contact. The area of theheel 562,toe 560, and portions of thetorsion bars 564 that contact the object may be relatively large relative compared to the to the force being applied, and therefore may be substantially atraumatic to the object being contacted. -
FIGS. 42A and 42B show another exemplary embodiment of an atraumatic tip 554 a that may be provided on alocator arm 552 a. Thelocator arm 552 a may be cut so that it has a taperedportion 566 a on its free end. Acoil 568 a may then be placed over the taperedportion 566 a, e.g., in a similar fashion as a guidewire tip, and may be soldered, welded, and/or bonded in place. Thus, thecoil 568 a may be provide an enlarged and/or resiliently deformable tip 554 a, which may reduce the risk of perforation or other damage to a vessel wall contacted by the tip 554 a. -
FIGS. 52A-52C show other alternative atraumatic tips that may be provided on locator arms described herein. For example,FIG. 52A shows anatraumatic tip 554 d that may be provided on a locator arm 552 d. Thetip 554 d may be formed by bending and/or curving the free end of the locator arm 552 d, e.g., such that thetip 554 d conforms substantially to the radius catheter (not shown) to which the locator arm 552 d is attached. Thus, thetip 554 d may extend around a portion of the circumference of the catheter while the locator arm 552 d extends along a length of the catheter, which may minimize a profile of the locator arm 552 d in the contracted condition. - Alternatively, as shown in
FIG. 52B , anatraumatic tip 554 e may be provided on alocator arm 552 e that includes anenlarged tab 567 e. Optionally, thetab 567 e may include a hole or recess 569 e (shown in phantom), which may be filled with a radiopaque material, if desired, to facilitate monitoring thelocator arm 552 e using fluoroscopy or other external imaging. In a further alternative, shown inFIG. 52C , anatraumatic tip 554 f may be provided on a locator arm 552 f that includes a pair ofcurved legs 570 f. Similar to theatraumatic tip 554 d described above, thelegs 570 f may include a radius corresponding to a radius of a catheter (not shown) to which the locator arm 552 f is attached, e.g., to minimize a profile of the locator arm 552 f in the contracted condition. Optionally, any of these features may be combined, e.g., provided together on a free end of a locator arm, such as including a tab on a curved leg (not shown). -
FIGS. 43A-43D show another embodiment of an atraumatic tip 554 b for alocator arm 552 b. In this set of Figures, thelocator arm 552 b may include threemoveable members static member 573 b, which may be attached to a catheter or may simulate a surface on a delivery catheter (not shown) to which themembers 572 b are attached. As themembers 572 b are moved from their retracted state shown inFIG. 43A to a progressively more deployed state shown inFIGS. 43B-43D , the distalmost member 574 b may rotate into a vertical orientation. Because the vessel walls that will be contacted with thelocator arm 552 b are expected to be substantially perpendicular to the catheter shaft, the distalmost locator arm 574 b may be substantially parallel to that surface in the configuration shown inFIG. 43D , providing maximum surface area for atraumatic contact. - Turning to
FIGS. 44A and 44B , an additional embodiment is shown for anatraumatic tip 554 c for alocator arm 552 c. As shown inFIG. 44B , a free end of thelocator arm 552 c may include a set ofconcentric loops 576 c cut into the end of it. Theseloops 576 c may be constructed, e.g., by thinning theloops 576 c, so that theloops 576 c are substantially flexible, e.g., may deform elastically or plastically when they come in contact with the patient's vasculature.FIG. 44B shows theatraumatic tip 554 c being deflected after contacting a wall of a trunk surrounding an ostium (not shown). As can be seen, theloops 576 c have deformed in response to the applied loads. This deformation prevents a large point load from being applied, and causing trauma to the patient. -
FIGS. 45A-45F show an exemplary embodiment of a locator device provided on a guide catheter 1010 for locating and positioning the guide catheter 1010 relative to an ostium. Generally, the guide catheter may be constructed similar to the embodiments described elsewhere herein. Once properly positioned, the guide catheter may be used to deliver astent 40 using a separate stent delivery catheter, such as those described in application Ser. No. 11/136,266, incorporated by reference above. -
FIGS. 46A-48B show alternative embodiments of an expandable mesh or braid locator device that is expanded using an underlying balloon.FIGS. 50A and 50B show a plurality of splines or arms that may be expanded using an underlying balloon to provide a locator device. Any of these embodiments may be provided on a guide catheter or other tubular member. The guide catheter may then be used to locate and/or position the guide catheter adjacent an ostium, e.g., for delivering a stent into the ostium. -
FIGS. 49A, 49B , 51A and 52B show embodiments of a locator device including a plurality of expandable arms or splines that are expanded by retracting an overlying sheath. The arms may be biased to extend outwardly when the sheath is retracted (FIGS. 49A and 49B ) or may be actuated to expand using the sheath (FIGS. 51A and 51B ). -
FIGS. 53A-54B show various embodiments of locator devices that include a braided mesh that may be compressed axially to cause the braid to buckle and expand radially outwardly.FIGS. 55A and 55B show a locator device including a plurality of splines or arms that may be unwound to expand and wound to contract.FIGS. 56A and 56B show a plurality of arms that may be preferentially buckled to expand radially outwardly to provide a locator device. -
FIGS. 57A-57C show a plurality of wires or arms that may be deployed from a guide catheter. The arms may be biased to curve or evert back on themselves, e.g., until they engage a receiver on the guide catheter, thereby providing a locator device. It will be appreciated that nay of these locator devices may be provided on a stent delivery catheter, guide catheter, or other device that may be introduced into a patient's body, e.g., using the methods described elsewhere herein. - It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein.
- While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the scope of the appended claims.
Claims (50)
1. An apparatus for locating an ostium of a body lumen, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends;
an elongate member comprising a distal portion disposed within the lumen such that the distal portion may be advanced beyond the tubular member distal end; and
an expandable loop on the distal portion, the loop comprising first and second ends fixed to the distal portion, first and second resilient struts extending from the first and second ends, respectively, and a curved intermediate region extending between the first and second struts, the loop being resiliently compressible to a contracted condition when the distal portion is disposed within the lumen and resiliently expandable to an enlarged condition when the distal portion is advanced beyond the tubular member distal end.
2. The apparatus of claim 1 , wherein the intermediate region defines an arcuate shape when the loop expands to the enlarged condition.
3. The apparatus of claim 2 , wherein the arcuate shape defines a portion of an ellipse surrounding the distal portion.
4. The apparatus of claim 1 , wherein the first and second struts extend transversely from the distal portion when the loop expands to the enlarged condition.
5. The apparatus of claim 4 , wherein the first and second struts extend distally from the distal portion when the loop expands to the enlarged condition.
6. The apparatus of claim 5 , further comprising a tubular prosthesis on the distal portion adjacent the first and second ends, the first and second struts extending over a portion of the prosthesis when the loops expands to the enlarged condition.
7. The apparatus of claim 1 , wherein the loop substantially defines a plane in the enlarged condition, the plane defining an acute angle with a longitudinal axis of the tubular member.
8. The apparatus of claim 7 , wherein the loop comprises an outer tip disposed away from the first and second ends, the outer tip extending out of the plane.
9. The apparatus of claim 1 , wherein only a single loop is provided on the distal portion of the tubular member.
10. The apparatus of claim 1 , wherein the expandable loop comprises a plurality of expandable loops.
11. The apparatus of claim 10 , wherein the plurality of expandable loops are disposed asymmetrically around a circumference of the tubular member.
12. The apparatus of claim 11 , wherein the plurality of expandable loops comprises curved intermediate regions that generally define a portion of an ellipse surrounding the distal portion.
13. The apparatus of claim 1 , wherein the loop substantially defines a “D” shape in the enlarged condition.
14. The apparatus of claim 1 , wherein the loop generally defines a curved shape in the enlarged condition define a surface extending transversely relative to a longitudinal axis of the tubular member.
15. The apparatus of claim 1 , wherein the loop comprises a plurality of wires wound around one another and extending between the first and second ends.
16. The apparatus of claim 1 , wherein the loop comprises a curved banana-peel shape in the enlarged condition.
17. The apparatus of claim 1 , wherein the loop is twisted asymmetrically relative to a longitudinal axis of the tubular member in the enlarged condition.
18. The apparatus of claim 17 , wherein the loop generally defines a plane in the enlarged condition, and wherein a normal axis extending from the plane does not extend substantially parallel to the longitudinal axis of the tubular member.
19. The apparatus of claim 17 , wherein the first strut extends more axially than the second strut in the enlarged condition.
20. The apparatus of claim 17 , wherein the first strut has a length that is shorter than the second strut.
21. The apparatus of claim 1 , wherein the struts are resiliently deflectable when the loops expands to the enlarged condition to provide tactile feedback when the intermediate region contacts an ostium.
22. The apparatus of claim 1 , wherein the struts extend axially when the loop is in the contracted condition.
23. The apparatus of claim 22 , wherein the intermediate region defines a serpentine shape when the loop is in the contracted condition.
24. The apparatus of claim 1 , wherein the loop comprises at least one of a wireform and a slotted tube.
25. An apparatus for locating an ostium of a body lumen, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends;
an elongate member comprising a distal portion disposed within the lumen such that the distal portion may be advanced beyond the tubular member distal end; and
a plurality of expandable loops on the distal portion, each loop comprising first and second resilient struts extending from the distal portion, and a curved intermediate region extending between the first and second struts, each loop being resiliently compressible to a contracted condition when the distal portion is disposed within the lumen and resiliently expandable to an enlarged condition when the distal portion is advanced beyond the tubular member distal end, the loops being disposed around the distal portion such that the intermediate regions define at least a portion of an ellipse surrounding the distal portion when the loops are in the enlarged condition.
26. The apparatus of claim 25 , wherein the first and second struts extend transversely from the distal portion when the loops expand to the enlarged condition.
27. The apparatus of claim 26 , wherein the first and second struts extend distally from the distal portion when the loops expand to the enlarged condition.
28. The apparatus of claim 27 , further comprising a tubular prosthesis on the distal portion adjacent the loops such that the first and second struts extend over a portion of the prosthesis when the loops expand to the enlarged condition.
29. The apparatus of claim 25 , wherein the struts are resiliently deflectable when the loops are expanded to the enlarged condition to provide tactile feedback when one or more of the intermediate regions contact an ostium.
30. The apparatus of claim 25 , wherein the struts extend axially when the loops are in the contracted condition.
31. The apparatus of claim 30 , wherein the intermediate regions define a serpentine shape when the loops are in the contracted condition.
32. The apparatus of claim 25 , wherein the loops comprise at least one of a wireform and a slotted tube.
33. An apparatus for locating an ostium of a body lumen, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion;
one or more locator elements disposed asymmetrically on the distal portion, each locator element comprising a first end fixed to the distal portion and a second end free from the distal portion, each locator element being resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device, each locator element being resiliently expandable to an enlarged condition when fully deployed from the delivery device; and
a stent on the distal portion.
34. The apparatus of claim 33 , wherein only a single locator element is disposed on the distal portion, the locator element extending transversely from the distal portion in the enlarged condition.
35. The apparatus of claim 33 , wherein the one or more locator elements comprise a plurality of locator elements, the locator elements disposed adjacent one another around only a portion of a circumference of the tubular member.
36. The apparatus of claim 35 , wherein the plurality of locator elements comprise outer curved portions that together define only a portion of an ellipse extending around a portion of the distal portion.
37. The apparatus of claim 33 , wherein the one or more locator elements comprise one or more wire loops.
38. An apparatus for locating an ostium of a body lumen, comprising:
a tubular member comprising a proximal end, a distal end sized for introduction into a body lumen, a lumen extending between the proximal and distal ends, and a distal portion; and
a locator loop on the distal portion that is resiliently compressible to a contracted condition when the distal portion is disposed within a lumen of a delivery device and is resiliently expandable to an enlarged condition when fully deployed from the delivery device, the locator loop comprising a loop that substantially surrounds the distal portion of the tubular member in the enlarged condition, and a plurality of struts extending between the loop and the distal portion for attaching the locator loop to the tubular member.
39. The apparatus of claim 38 , wherein the struts comprise an inner portion closer to the tubular member and an outer portion closer to the loop, the inner portion being more rigid than the outer portion.
40. The apparatus of claim 39 , wherein the inner portion has at least one of a width and a thickness that is greater than the outer portion.
41. The apparatus of claim 38 , further comprising one or more supports extending between adjacent struts at intermediate regions of the struts.
42. The apparatus of claim 38 , wherein the locator loop comprises a base attached to the distal portion of the tubular member, the struts extending from the base.
43. The apparatus of claim 42 , wherein the base and the struts are formed from a unitary tubular body.
44. The apparatus of claim 43 , wherein the loop is formed from the unitary tubular body.
45. The apparatus of claim 43 , wherein the loop defines a serpentine shape in the contracted condition, the loop being heat treated to expand resiliently to the enlarged condition from the serpentine shape when deployed from the delivery device.
46. The apparatus of claim 43 , wherein the loop is formed from one or more wires attached to the unitary tubular body.
47. A method for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen, comprising:
advancing a distal end of a delivery catheter into the main body lumen, the distal end comprising one or more locator elements constrained in a contracted condition;
releasing the one or more locator elements within the main body lumen, the one or more locator elements resiliently expanding asymmetrically;
directing the one or more locator elements against a wall of the ostium, the one or more locator elements causing the distal end of the delivery catheter to rotate about its longitudinal axis; and
performing a procedure at or within the ostium based upon the position of the one or more locator elements in the enlarged condition.
48. The method of claim 47 , further comprising advancing the distal end after the one or more locator elements expand towards the enlarged condition, the one or more locator elements providing tactile feedback resisting further advancement when the one or more locator elements contact the main body lumen wall adjacent the ostium.
49. The method of claim 47 , wherein the procedure comprises delivering a stent within at least one of the ostium and the branch.
50. A method for delivering a stent within an ostium communicating from a main body lumen to a branch body lumen, comprising:
advancing a distal end of a delivery catheter into the main body lumen, the distal end comprising one or more locator elements constrained in a contracted condition;
releasing the one or more locator elements within the main body lumen, the one or more locator elements resiliently expanding to substantially surround the distal end;
directing the one or more locator elements against a wall of the ostium, thereby causing one or more struts supporting the one or more locator elements to bend away from the ostium; and
performing a procedure at or within the ostium based upon the position of the one or more locator elements in the enlarged condition.
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Also Published As
Publication number | Publication date |
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CA2609427A1 (en) | 2006-11-30 |
EP1906877A1 (en) | 2008-04-09 |
US20070021828A1 (en) | 2007-01-25 |
JP2008541873A (en) | 2008-11-27 |
WO2006127825A1 (en) | 2006-11-30 |
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